Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3610.......................  High Pressure      PVD..............  LAG..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Methamphetamine.                                         employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3610.......................  Test,              PVD..............  NGG..............  Exemption is limited
                                  Methamphetamine,                                         to test systems
                                  Over The Counter.                                        intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3620.......................  Enzyme             PVE..............  DJR..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Methadone.                                               intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3620.......................  Hemagglutination   PVE..............  DIW..............  Exemption is limited
                                  Inhibition,                                              to test systems
                                  Methadone.                                               intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3620.......................  Gas                PVE..............  DMB..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methadone.                                               intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)

862.3620.......................  Thin Layer         PVE..............  DKR..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methadone.                                               intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3620.......................  Liquid             PVE..............  DNT..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methadone.                                               intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3620.......................  Free Radical       PVE..............  DPP..............  Exemption is limited
                                  Assay, Methadone.                                        to test systems
                                                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3630.......................  Radioimmunoassay,  PVF..............  KXS..............  Exemption is limited
                                  Methaqualone.                                            to test systems
                                                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3640.......................  Thin Layer         PVG..............  DNK..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Morphine.                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3640.......................  Radioimmunoassay,  PVG..............  DOE..............  Exemption is limited
                                  Morphine (123-                                           to test systems
                                  I), Goat                                                 intended for
                                  Antibody                                                 employment and
                                  Ammonium Sulfate                                         insurance testing
                                  Sep..                                                    that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3640.......................  Fluorometry,       PVG..............  DJJ..............  Exemption is limited
                                  Morphine.                                                to test systems
                                                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3640.......................  Liquid             PVG..............  DPK..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Morphine.                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)

862.3640.......................  Gas                PVG..............  DMY..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Morphine.                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3640.......................  Hemagglutination   PVG..............  DLR..............  Exemption is limited
                                  Inhibition,                                              to test systems
                                  Morphine.                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3640.......................  Free Radical       PVG..............  DOK..............  Exemption is limited
                                  Assay, Morphine.                                         to test systems
                                                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3640.......................  Radioimmunoassay,  PVG..............  DIQ..............  Exemption is limited
                                  Morphine (3-H),                                          to test systems
                                  Goat Antibody                                            intended for
                                  Ammonium Sulfate                                         employment and
                                  Sep..                                                    insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3640.......................  Radioimmunoassay,  PVG..............  DNA..............  Exemption is limited
                                  Morphine-                                                to test systems
                                  Barbiturate (125-                                        intended for
                                  I), Goat                                                 employment and
                                  Antibody.                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3650.......................  Enzyme             PVH..............  DJG..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Opiates.                                                 intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3650.......................  Gas                PVH..............  DJF..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Opiates.                                                 intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3650.......................  Hemagglutination,  PVH..............  DLT..............  Exemption is limited
                                  Opiates.                                                 to test systems
                                                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)

862.3650.......................  Thin Layer         PVH..............  LAI..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Opiates.                                                 intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3650.......................  Free Radical       PVH..............  DKT..............  Exemption is limited
                                  Assay, Opiates.                                          to test systems
                                                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3650.......................  High Pressure      PVH..............  LAH..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Opiates.                                                 employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3700.......................  Enzyme             PVI..............  JXN..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Propoxyphene.                                            intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3700.......................  Thin Layer         PVI..............  DPN..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Propoxyphene.                                            intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3700.......................  Gas                PVI..............  LAJ..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Propoxyphene.                                            intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3700.......................  High Pressure      PVI..............  LAK..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Propoxyphene.                                            employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3870.......................  Enzyme             PVJ..............  LDJ..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Cannabinoids.                                            intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)

862.3870.......................  Reagents, Test,    PVJ..............  DKE..............  Exemption is limited
                                  Tetrahydrocannab                                         to test systems
                                  inol.                                                    intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3870.......................  Radioimmunoassay,  PVJ..............  LAT..............  Exemption is limited
                                  Cannabinoid(S).                                          to test systems
                                                                                intended for
                                                                                employment and
                                                                                insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3910.......................  High Pressure      PVK..............  LFI..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Tricyclic                                                employment and
                                  Antidepressant                                           insurance testing
                                  Drugs.                                                   that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3910.......................  U.V.               PVK..............  LFH..............  Exemption is limited
                                  Spectrometry,                                            to test systems
                                  Tricyclic                                                intended for
                                  Antidepressant                                           employment and
                                  Drugs.                                                   insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
862.3910.......................  Thin Layer         PVK..............  MLK..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Tricyclic                                                intended for
                                  Antidepressant                                           employment and
                                  Drugs.                                                   insurance testing
                                                                                that include a
                                                                                statement in their
                                                                                labeling that the
                                                                                device is intended
                                                                                solely for use in
                                                                                employment and
                                                                                insurance testing,
                                                                                and does not include
                                                                                test systems intended
                                                                                for Federal drug
                                                                                testing programs
                                                                                (e.g., programs run
                                                                                by the Substance
                                                                                Abuse and Mental
                                                                                Health Services
                                                                                Administration
                                                                                (SAMHSA), the
                                                                                Department of
                                                                                Transportation (DOT),
                                                                                and the U.S.
                                                                                military.)
866.5750.......................  System, Test,      PUW..............  DHB..............  Exemption is limited
                                  Radioallergosorb                                         to devices classified
                                  ent (RAST)                                               under 21 CFR 866.5750
                                  Immunological.                                           that are intended to
                                                                                detect any of the
                                                                                allergens included in
                                                                                table 3 of this
                                                                                document.
868.2385.......................  Analyzer,          PUG..............  MRQ..............  Exemption is limited
                                  Nitrogen Dioxide.                                        to standalone
                                                                                nitrogen dioxide
                                                                                analyzers and not
                                                                                those that are
                                                                                components of nitric
                                                                                oxide delivery
                                                                                systems intended to
                                                                                monitor nitrogen
                                                                                dioxide levels during
                                                                                inhaled nitric oxide
                                                                                therapy.
870.1330.......................  Wire, Guide,       PTL..............  DQX..............  Exemption is limited
                                  Catheter.                                                to accessory torque
                                                                                devices that are
                                                                                manually operated,
                                                                                non-patient
                                                                                contacting, and
                                                                                intended to
                                                                                manipulate non-
                                                                                cerebral vascular
                                                                                guide wires.
870.1650.......................  Syringe, Balloon   PTM..............  MAV..............  Exemption is limited
                                  Inflation.                                               to non-patient
                                                                                contacting balloon
                                                                                inflation syringes
                                                                                intended only to
                                                                                inflate/deflate
                                                                                balloon catheters and
                                                                                monitor pressure
                                                                                within the balloon.
870.2770.......................  Analyzer, Body     PUH..............  MNW..............  Exemption is limited
                                  Composition.                                             to body composition
                                                                                analyzers which are
                                                                                not intended to
                                                                                diagnose or treat any
                                                                                medical condition.
870.4400.......................  Reservoir, Blood,  PTN..............  DTN..............  Exemption is limited
                                  Cardiopulmonary                                          to cardiopulmonary
                                  Bypass.                                                  bypass blood
                                                                                reservoirs that do
                                                                                not contain defoamers
                                                                                or blood filters.
874.1090.......................  Tester, Auditory   PTO..............  ETY..............  Exemption is limited
                                  Impedance.                                               to auditory impedance
                                                                                testers that are in
                                                                                compliance with FDA-
                                                                                recognized consensus
                                                                                standard ANSI S3.39.
874.1090.......................  Tympanometer.....  PTP..............  NAS..............  Exemption is limited
                                                                                to tympanometers that
                                                                                are in compliance
                                                                                with FDA-recognized
                                                                                consensus standard
                                                                                ANSI S3.39.
876.1500.......................  Endoscopic         PTQ..............  FCC..............  Exemption is limited
                                  Magnetic                                                 to endoscopic
                                  Retriever.                                               magnetic retrievers
                                                                                intended for single
                                                                                use.
876.1500.......................  Scissors For       PTR..............  KGD..............  Exemption is limited
                                  Cystoscope.                                              to sterile scissors
                                                                                for cystoscope
                                                                                intended for single
                                                                                use.

876.1500.......................  Endoscopic         PTS..............  OCZ..............  Exemption is limited
                                  Grasping/Cutting                                         to disposable, non-
                                  Instrument, Non-                                         powered endoscopic
                                  Powered.                                                 grasping/cutting
                                                                                instruments intended
                                                                                for single use.
876.5010.......................  Catheter,          PTT..............  GCA..............  Exemption is limited
                                  Biliary,                                                 to surgical biliary
                                  Surgical.                                                catheters that do not
                                                                                include a balloon
                                                                                component.
876.5630.......................  Catheter,          PTU..............  FJS..............  Exemption is limited
                                  Peritoneal, Long-                                        to non-patient
                                  Term Indwelling.                                         contacting catheter
                                                                                finger grips intended
                                                                                for single use.
876.5630.......................  Catheter,          PTV..............  FKO..............  Exemption is limited
                                  Peritoneal                                               to non-patient
                                  Dialysis, Single                                         contacting catheter
                                  Use.                                                     finger grips intended
                                                                                for single use.
876.5630.......................  System,            PTW..............  FKX..............  Exemption is limited
                                  Peritoneal,                                              to continuous
                                  Automatic                                                ambulatory peritoneal
                                  Delivery.                                                dialysis (CAPD) belts
                                                                                and catheter stands
                                                                                that do not include
                                                                                weigh scales.
878.4370.......................  Drape, Surgical..  PUI..............  KKX..............  Exemption is limited
                                                                                to surgical drapes
                                                                                that do not include
                                                                                an antimicrobial
                                                                                agent.
878.4495.......................  Suture,            PTX..............  GAQ..............  Exemption is limited
                                  Nonabsorbable,                                           to steel monofilament
                                  Steel,                                                   sutures that are
                                  Monofilament And                                         uncoated and do not
                                  Multifilament,                                           incorporate barbs.
                                  Sterile.
882.1470.......................  Computerized       PTY..............  PKQ..............  Exemption is limited
                                  Cognitive                                                to computerized
                                  Assessment Aid.                                          cognitive assessment
                                                                                aids that are not
                                                                                intended for
                                                                                diagnostic assessment
                                                                                of specific diseases
                                                                                or conditions and
                                                                                rely on inputs from
                                                                                visual cues, auditory
                                                                                cues, and/or
                                                                                functional use of the
                                                                                hand.
884.1630.......................  Colposcope (and    PTZ..............  HEX..............  Exemption is limited
                                  Colpomicroscope).                                        to standard
                                                                                colposcopes (and
                                                                                colpomicroscopes)
                                                                                that use only a white
                                                                                light source, do not
                                                                                use filters other
                                                                                than a green filter,
                                                                                do not include image
                                                                                analysis software,
                                                                                and are not
                                                                                smartphone-based.
884.4530.......................  Tenaculum,         PUA..............  HDC..............  Exemption is limited
                                  Uterine.                                                 to sterile uterine
                                                                                tenaculum devices
                                                                                that do not use
                                                                                suction and are
                                                                                intended for single
                                                                                use.
884.6120.......................  Accessory,         PUB..............  MQG..............  Exemption is limited
                                  Assisted                                                 to simple embryo
                                  Reproduction.                                            incubators with
                                                                                temperature, gas, and
                                                                                humidity control
                                                                                only; syringe pumps;
                                                                                collection tube
                                                                                warmers; dish/plate/
                                                                                microscope stage
                                                                                warmers; and
                                                                                controlled-rate
                                                                                cryopreservation
                                                                                freezers.
884.6130.......................  Microtools,        PUC..............  MQH..............  Exemption is limited
                                  Assisted                                                 to assisted
                                  Reproduction                                             reproduction
                                  (Pipettes).                                              microtools (pipettes)
                                                                                manufactured from
                                                                                glass.
884.6160.......................  Labware, Assisted  PUD..............  MQK..............  Exemption is limited
                                  Reproduction.                                            to dishes and plates
                                                                                that are intended for
                                                                                general assisted
                                                                                reproduction
                                                                                technology
                                                                                procedures.
886.1850.......................  Biomicroscope,     PUE..............  HJO..............  Exemption is limited
                                  Slit-Lamp, AC-                                           to slit-lamp, AC-
                                  Powered.                                                 powered
                                                                                biomicroscopes
                                                                                intended only for the
                                                                                visual examination of
                                                                                the anterior segment
                                                                                of the eye, are
                                                                                classified as Group 1
                                                                                per FDA-recognized
                                                                                consensus standard
                                                                                ANSI Z80.36, do not
                                                                                provide any
                                                                                quantitative output,
                                                                                and are not intended
                                                                                for screening or
                                                                                automated diagnostic
                                                                                indications.
886.3320.......................  Ocular Peg.......  PUF..............  MQU..............  Exemption is limited
                                                                                to ocular pegs
                                                                                supplied sterile.
----------------------------------------------------------------------------------------------------------------

    In table 2, FDA included devices classified under Sec.  866.5750
(Radioallergosorbent (RAST) immunological test system). FDA does not
believe that all devices classified under this regulation meet the
exemption criteria from premarket notification requirements. The
devices listed in table 3 are also classified under Sec.  866.5750, but
this subset no longer requires premarket notification under section
510(k) of the FD&C Act, subject to the general limitations to the
exemptions found in Sec.  866.9. While the non-exempt devices
classified under Sec.  866.5750 will retain product code ``DHB'', these
devices listed in table 3 are reassigned product code ``PUW.''

                        Table 3--Class II Devices
[Sec.   866.5750--Radioallergosorbent (RAST) Immunological Test Systems]
------------------------------------------------------------------------
                                                   Source (taxonomical
     Allergen code          Allergen product              name)
------------------------------------------------------------------------
                              Grass Pollens
------------------------------------------------------------------------
g1....................  Sweet vernal grass.....  Anthoxanthum odoratum.
g3....................  Cocksfoot grass,         Dactylis glomerata.
                         Orchard grass.
g4....................  Meadow fescue..........  Festuca elatior.
g5....................  Rye-grass (perennial     Lolium perenne.
                         rye grass).
g7....................  Common reed (common      Phragmites communis.
                         reed grass).
g8....................  Meadow grass, Kentucky   Poa pratensis.
                         blue (June grass).

g9....................  Redtop, Bentgrass......  Agrostis stolonifera
                                                 Agrostis gigantea
                                                  (Agrostis alba).
g11...................  Brome grass............  Bromus inermis.
g12...................  Cultivated rye           Secale cereale.
                         (cultivated rye grass).
g13...................  Velvet grass...........  Holcus lanatus.
g14...................  Cultivated oat           Avena sativa.
                         (cultivated oat grass).
g15...................  Cultivated wheat         Triticum aestivum
                         (cultivated wheat       (Triticum spp.).
                         grass).
g16...................  Meadow foxtail (meadow   Alopecurus pratensis.
                         foxtail grass).
g17...................  Bahia grass............  Paspalum notatum.
g24...................  Wheat grass, Western...  Agropyron smithii
                                                 (Elymus smithii).
g30...................  Bluegrass, annual......  Poa annua.
g70...................  Wild rye grass.........  Elymus triticoides
                                                 Elymus condensatus.
g71...................  Canary grass...........  Phalaris arundinacea.
g201..................  Barley, cultivated.....  Hordeum vulgare.
g202..................  Maize, corn (cultivated  Zea mays.
                         corn).
g203..................  Salt grass.............  Distichlis spicata.
g204..................  False oat-grass........  Arrhenatherum elatius.
g216..................  Cyn d 1................  Cynodon dactylon.
g701..................  Phl p 1.0102, Phl p      Phleum pratense.
                         5.0101.
g702..................  Phl p 7.0101...........  Phleum pratense.
g703..................  Phl p 12.0101..........  Phleum pratense.
------------------------------------------------------------------------
                              Weed Pollens
------------------------------------------------------------------------
w2....................  Western ragweed........  Ambrosia psilostachya.
w4....................  False ragweed..........  Ambrosia acanthicarpa
                                                 (Franseria
                                                  acanthicarpa).
w5....................  Wormwood...............  Artemisia absinthium
                                                 Artemisia annua.
w6....................  Mugwort................  Artemisia vulgaris.
w7....................  Marguerite, ox-eye       Chrysanthemum
                         daisy.                   leucanthemum.
w8....................  Dandelion..............  Taraxacum vulgare
                                                 Taraxacum officinale.
w9....................  Plantain (English),      Plantago lanceolata.
                         Ribwort.
w10...................  Goosefoot, lamb's        Chenopodium album.
                         quarters.
w11...................  Saltwort (prickly),      Salsola kali
                         Russian thistle.        (Salsola pestifer).
w12...................  Goldenrod..............  Solidago virgaurea
                                                 (Solidago spp.)
w13...................  Cocklebur, common......  Xanthium commune.
w14...................  Common pigweed (rough    Amaranthus retroflexus.
                         pigweed).
w15...................  Scale, Lenscale........  Atriplex lentiformis.
w16...................  Rough marsh elder......  Iva ciliate
                                                 Iva annua.
w17...................  Firebush (Kochia)......  Kochia scoparia.
w18...................  Sheep sorrel...........  Rumex acetosella.
w19...................  Wall pellitory.........  Parietaria officinalis.
w20...................  Nettle (Common stinging  Urtica dioica.
                         nettle).
w21...................  Wall pellitory.........  Parietaria judaica.
w22...................  Japanese hop (careless   Humulus japonicas
                         weed).                  (Humulus scandens).
w23...................  Yellow dock, Yellow      Rumex crispus.
                         dockweed.
w24...................  Spiny pigweed..........  Amaranthus spinosus.
w27...................  Carnation..............  Dianthus spp.
w28...................  Rose...................  Rosa rugosa.
w33...................  Clover.................  Trifolium pratense.
w35...................  Mexican tea............  Chenopodium
                                                  ambrosioides.
w36...................  Rabbit bush............  Ambrosia deltoidea
                                                 (Franseria deltoides).
w37...................  Salt bush, annual......  Atriplex wrightii.
w39...................  Water hemp, Western....  Amaranthus rudis
                                                 (Acnida tamariscina).
w41...................  Burrobrush.............  Hymenoclea salsola.
w42...................  Poverty weed...........
w43...................  Common sagebrush.......  Artemisia tridentata.
w45...................  Alfalfa................  Medicago sativa.
w46...................  Dog fennel.............  Eupatorium
                                                  capillifolium.

w53...................  Geranium...............  Geranium spp.
w67...................  Groundsel bush.........  Baccharis halimifolia.
w69...................  Iodine bush............  Allenrolfea
                                                  occidentalis.
w70...................  Ragweed, slender.......  Ambrosia confertiflora.
w75...................  Wing scale (wingscale).  Atriplex canescens.
w82...................  Careless weed..........  Amaranthus palmeri
                                                 Amaranthus hybridus.
w90...................  Japanese hop...........  Humulus japonicas
                                                 (Humulus scandens).
w203..................  Rape (rape pollen).....  Brassica napus.
w204..................  Sunflower..............  Helianthus annuus.
w206..................  Camomile...............  Matricaria chamomilla.
w207..................  Lupin..................  Lupinus spp.
w210..................  Sugar-beet.............  Beta vulgaris.
w211..................  Par j 2.0101...........  Parietaria judaica.
w231..................  Art v 1................  Artemisia vulgaris
                                                  (Mugwort).
w232..................  Sal k 1................  Salsola kali.
w233..................  Art v 3................  Artemisa vulgaris (LTP,
                                                  Mugwort).
w234..................  Pla l 1................  Plantago lanceolata.
w235..................  Che a 1.0101...........  Chenopodium album.
w236..................  Mer a 1.0101...........  Mercurialis annua.
a753..................  Art v 1................  Artemisia vulgaris
                                                  (Mugwort weed).
------------------------------------------------------------------------
                              Tree Pollens
------------------------------------------------------------------------
t1....................  Box-elder (Maple)......  Acer negundo.
                                                 Acer saccharum.
t2....................  Gray alder, speckled     Alnus incana.
                         alder (alder).
t4....................  Hazel, hazelnut........  Corylus avellana.
                                                 Corylus americana.
t5....................  American beech (beech).  Fagus grandifolia.
                                                 (Fagus americana).
t6....................  Mountain juniper,        Juniperus ashei
                         Mountain cedar.         (Juniperus sabinoides).
t8....................  Elm....................  Ulmus americana.
t9....................  Olive..................  Olea europaea.
t10...................  Walnut.................  Juglans californica
                                                 Juglans nigra.
t11...................  Maple leaf sycamore,     Platanus acerifolia.
                         London plane, Plane
                         tree.
t61...................  Sycamore...............  Platanus occidentalis.
t12...................  Willow.................  Salix caprea
                                                 Salix nigra.
t14...................  Cottonwood (Eastern      Populus deltoides.
                         Cottonwood/Black
                         Cottonwood).
t15...................  White ash..............  Fraxinus americana.
t16...................  White pine.............  Pinus strobus.
t18...................  Eucalyptus, gum-tree...  Eucalyptus globulus.
                                                 (Eucalyptus spp.).
t19/t26...............  Acacia.................  Acacia longifolia