862.3100 | Enzyme Immunoassay, Amphetamine | PUX | DKZ | Exemption is limited 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.) |
862.3100 | Radioimmunoassay, Amphetamine | PUX | DJP | Exemption is limited 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.) |
862.3100 | Thin Layer Chromatography, Amphetamine | PUX | DIT | Exemption is limited 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.) |
862.3100 | Gas Chromatography, Amphetamine | PUX | DOD | Exemption is limited 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.) |
862.3100 | Liquid Chromatography, Amphetamine | PUX | DNI | Exemption is limited 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.) |
862.3100 | Free Radical Assay, Amphetamine | PUX | DJL | Exemption is limited 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.) |
862.3150 | Enzyme Immunoassay, Barbiturate | PUY | DIS | Exemption is limited 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.) |
Start Printed Page 31982 |
862.3150 | Radioimmunoassay, Barbiturate | PUY | DKN | Exemption is limited 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.) |
862.3150 | Thin Layer Chromatography, Barbiturate | PUY | DKX | Exemption is limited 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.) |
862.3150 | Mercury Dithiazone, Colorimetry, Barbiturate | PUY | DJN | Exemption is limited 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.) |
862.3150 | Hemagglutination Inhibition, Barbiturate | PUY | DLX | Exemption is limited 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.) |
862.3150 | Gas Liquid Chromatography, Barbiturate | PUY | DMF | Exemption is limited 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.) |
862.3150 | High Pressure Liquid Chromatography, Barbiturate | PUY | KZY | Exemption is limited 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.) |
862.3170 | Enzyme Immunoassay, Benzodiazepine | PUZ | JXM | Exemption is limited 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.) |
862.3170 | High Pressure Liquid Chromatography, Benzodiazepine | PUZ | LAA | Exemption is limited 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.) |
Start Printed Page 31983 |
862.3170 | Test, Benzodiazepine, Over The Counter | PUZ | NFV | Exemption is limited 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.) |
862.3170 | Gas Chromatography, Benzodiazepine | PUZ | KZZ | Exemption is limited 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.) |
862.3170 | Thin Layer Chromatography, Benzodiazepine | PUZ | LAB | Exemption is limited 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.) |
862.3250 | Enzyme Immunoassay, Cocaine and Cocaine Metabolites | PVA | DIO | Exemption is limited 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.) |
862.3250 | Radioimmunoassay, Cocaine Metabolite | PVA | KLN | Exemption is limited 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.) |
862.3250 | Enzyme Immunoassay, Cocaine | PVA | JXO | Exemption is limited 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.) |
862.3250 | Hemagglutination, Cocaine Metabolites (Benzoylecgonine) | PVA | DLN | Exemption is limited 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.) |
862.3250 | Thin Layer Chromatography, Cocaine | PVA | DMN | Exemption is limited 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.) |
Start Printed Page 31984 |
862.3250 | Free Radical Assay, Cocaine | PVA | DIR | Exemption is limited 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.) |
862.3250 | Gas Chromatography, Cocaine | PVA | DIN | Exemption is limited 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.) |
862.3250 | Thin Layer Chromatography, Benzoylecgonine | PVA | DOM | Exemption is limited 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.) |
862.3250 | High Pressure Liquid Chromatography, Cocaine and Cocaine Metabolites | PVA | LAC | Exemption is limited 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.) |
862.3270 | High Pressure Liquid Chromatography, Codeine | PVB | LAE | Exemption is limited 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.) |
862.3270 | Thin Layer Chromatography, Codeine | PVB | DLD | Exemption is limited 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.) |
862.3270 | Gas Chromatography, Codeine | PVB | LAD | Exemption is limited 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.) |
862.3580 | Radioimmunoassay, LSD (125-I) | PVC | DLB | Exemption is limited 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.) |
Start Printed Page 31985 |
862.3580 | Free Radical Assay, LSD | PVC | DOL | Exemption is limited 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.) |
862.3610 | Gas Chromatography, Methamphetamine | PVD | LAF | Exemption is limited 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.) |
862.3610 | Thin Layer Chromatography, Methamphetamine | PVD | DJC | Exemption is limited 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.) |
862.3610 | High Pressure Liquid Chromatography, Methamphetamine | PVD | LAG | Exemption is limited 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.) |
862.3610 | Test, Methamphetamine, Over The Counter | PVD | NGG | Exemption is limited 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.) |
862.3620 | Enzyme Immunoassay, Methadone | PVE | DJR | Exemption is limited 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.) |
862.3620 | Hemagglutination Inhibition, Methadone | PVE | DIW | Exemption is limited 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.) |
862.3620 | Gas Chromatography, Methadone | PVE | DMB | Exemption is limited 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.) |
Start Printed Page 31986 |
862.3620 | Thin Layer Chromatography, Methadone | PVE | DKR | Exemption is limited 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.) |
862.3620 | Liquid Chromatography, Methadone | PVE | DNT | Exemption is limited 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.) |
862.3620 | Free Radical Assay, Methadone | PVE | DPP | Exemption is limited 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, Methaqualone | PVF | KXS | Exemption is limited 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 Chromatography, Morphine | PVG | DNK | Exemption is limited 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, Morphine (123-I), Goat Antibody Ammonium Sulfate Sep. | PVG | DOE | Exemption is limited 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 | Fluorometry, Morphine | PVG | DJJ | Exemption is limited 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 Chromatography, Morphine | PVG | DPK | Exemption is limited 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.) |
Start Printed Page 31987 |
862.3640 | Gas Chromatography, Morphine | PVG | DMY | Exemption is limited 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 | Hemagglutination Inhibition, Morphine | PVG | DLR | Exemption is limited 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 | Free Radical Assay, Morphine | PVG | DOK | Exemption is limited 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, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep. | PVG | DIQ | Exemption is limited 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, Morphine-Barbiturate (125-I), Goat Antibody | PVG | DNA | Exemption is limited 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 | Enzyme Immunoassay, Opiates | PVH | DJG | Exemption is limited 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 | Gas Chromatography, Opiates | PVH | DJF | Exemption is limited 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 | Hemagglutination, Opiates | PVH | DLT | Exemption is limited 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.) |
Start Printed Page 31988 |
862.3650 | Thin Layer Chromatography, Opiates | PVH | LAI | Exemption is limited 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 | Free Radical Assay, Opiates | PVH | DKT | Exemption is limited 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 Liquid Chromatography, Opiates | PVH | LAH | Exemption is limited 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.) |
862.3700 | Enzyme Immunoassay, Propoxyphene | PVI | JXN | Exemption is limited 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.) |
862.3700 | Thin Layer Chromatography, Propoxyphene | PVI | DPN | Exemption is limited 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.) |
862.3700 | Gas Chromatography, Propoxyphene | PVI | LAJ | Exemption is limited 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.) |
862.3700 | High Pressure Liquid Chromatography, Propoxyphene | PVI | LAK | Exemption is limited 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.) |
862.3870 | Enzyme Immunoassay, Cannabinoids | PVJ | LDJ | Exemption is limited 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.) |
Start Printed Page 31989 |
862.3870 | Reagents, Test, Tetrahydrocannabinol | PVJ | DKE | Exemption is limited 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.) |
862.3870 | Radioimmunoassay, Cannabinoid(S) | PVJ | LAT | Exemption is limited 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 Liquid Chromatography, Tricyclic Antidepressant Drugs | PVK | LFI | Exemption is limited 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 | U.V. Spectrometry, Tricyclic Antidepressant Drugs | PVK | LFH | Exemption is limited 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 | Thin Layer Chromatography, Tricyclic Antidepressant Drugs | PVK | MLK | Exemption is limited 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.) |
866.5750 | System, Test, Radioallergosorbent (RAST) Immunological | PUW | DHB | Exemption is limited to devices classified under 21 CFR 866.5750 that are intended to detect any of the allergens included in table 3 of this document. |
868.2385 | Analyzer, Nitrogen Dioxide | PUG | MRQ | Exemption is limited 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, Catheter | PTL | DQX | Exemption is limited to accessory torque devices that are manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires. |
870.1650 | Syringe, Balloon Inflation | PTM | MAV | Exemption is limited to non-patient contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon. |
870.2770 | Analyzer, Body Composition | PUH | MNW | Exemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition. |
870.4400 | Reservoir, Blood, Cardiopulmonary Bypass | PTN | DTN | Exemption is limited to cardiopulmonary bypass blood reservoirs that do not contain defoamers or blood filters. |
874.1090 | Tester, Auditory Impedance | PTO | ETY | Exemption is limited 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 Magnetic Retriever | PTQ | FCC | Exemption is limited to endoscopic magnetic retrievers intended for single use. |
876.1500 | Scissors For Cystoscope | PTR | KGD | Exemption is limited to sterile scissors for cystoscope intended for single use. |
Start Printed Page 31990 |
876.1500 | Endoscopic Grasping/Cutting Instrument, Non-Powered | PTS | OCZ | Exemption is limited to disposable, non-powered endoscopic grasping/cutting instruments intended for single use. |
876.5010 | Catheter, Biliary, Surgical | PTT | GCA | Exemption is limited to surgical biliary catheters that do not include a balloon component. |
876.5630 | Catheter, Peritoneal, Long-Term Indwelling | PTU | FJS | Exemption is limited to non-patient contacting catheter finger grips intended for single use. |
876.5630 | Catheter, Peritoneal Dialysis, Single Use | PTV | FKO | Exemption is limited to non-patient contacting catheter finger grips intended for single use. |
876.5630 | System, Peritoneal, Automatic Delivery | PTW | FKX | Exemption is limited to continuous ambulatory peritoneal 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, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | PTX | GAQ | Exemption is limited to steel monofilament sutures that are uncoated and do not incorporate barbs. |
882.1470 | Computerized Cognitive Assessment Aid | PTY | PKQ | Exemption is limited to computerized 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 Colpomicroscope) | PTZ | HEX | Exemption is limited 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, Uterine | PUA | HDC | Exemption is limited to sterile uterine tenaculum devices that do not use suction and are intended for single use. |
884.6120 | Accessory, Assisted Reproduction | PUB | MQG | Exemption is limited to simple embryo 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, Assisted Reproduction (Pipettes) | PUC | MQH | Exemption is limited to assisted reproduction microtools (pipettes) manufactured from glass. |
884.6160 | Labware, Assisted Reproduction | PUD | MQK | Exemption is limited to dishes and plates that are intended for general assisted reproduction technology procedures. |
886.1850 | Biomicroscope, Slit-Lamp, AC-Powered | PUE | HJO | Exemption is limited to slit-lamp, AC-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. |