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| Product | Model | Company | Device type |
|---|---|---|---|
| AccuSign® MTD cardPrinceton Biomeditech CorporationMethadone IVD, kit, rapid ICT, clinical | DOA-208-10-02 | Princeton Biomeditech Corporation | Methadone IVD, kit, rapid ICT, clinical |
| Accutest CLEAR Opiates Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitJant Pharmacal CorporationOpiate/opiate metabolite IVD, kit, rapid ICT, clinical | DS317 | Jant Pharmacal Corporation | Opiate/opiate metabolite IVD, kit, rapid ICT, clinical |
| Accutest iFOBT - Dual Sample Fecal Occult Blood TestJant Pharmacal CorporationFaecal occult blood IVD, kit, rapid ICT, clinical | CS612 | Jant Pharmacal Corporation | Faecal occult blood IVD, kit, rapid ICT, clinical |
| Advin Multi-Drug Screen TestAdvin Biotech, Inc.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | 1 | Advin Biotech, Inc. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| AIMSCREEN METGermaine Laboratories, IncMethamphetamine-specific IVD, kit, rapid ICT, clinical | 47125 | Germaine Laboratories, Inc | Methamphetamine-specific IVD, kit, rapid ICT, clinical |
| AlereTM iScreen®Instant Technologies, Inc.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | IS1MET | Instant Technologies, Inc. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| Alltest COC150 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical | 1 | Hangzhou AllTest Biotech Co., Ltd. | Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical |
| Alltest COC150 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical | 1 | Hangzhou AllTest Biotech Co., Ltd. | Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical |
| Alltest MET500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.Methamphetamine-specific IVD, kit, rapid ICT, clinical | 1 | Hangzhou AllTest Biotech Co., Ltd. | Methamphetamine-specific IVD, kit, rapid ICT, clinical |
| AmazewellGuangzhou Decheng Biotechnology Co., LTDAmphetamine-specific IVD, kit, rapid ICT, clinical | DPO-744EUO | Guangzhou Decheng Biotechnology Co., LTD | Amphetamine-specific IVD, kit, rapid ICT, clinical |
| At Home Drug Test for MarijuanaPhamatech, IncorporatedCannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical | 9078T | Phamatech, Incorporated | Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical |
| Atida Fentanyl Drug of Abuse TestAceso Laboratories Inc.Fentanyl IVD, kit, rapid ICT, clinical | U02CW-FYL-US | Aceso Laboratories Inc. | Fentanyl IVD, kit, rapid ICT, clinical |
| Benzodiazepines Panel DipAssure Tech. (Hangzhou) Co., Ltd.Benzodiazepine group IVD, kit, rapid ICT, clinical | 1.0 | Assure Tech. (Hangzhou) Co., Ltd. | Benzodiazepine group IVD, kit, rapid ICT, clinical |
| CERTUM mAMP One Step Methamphetamine Test StripAlere San Diego, Inc.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | DME-101-a-Sgl | Alere San Diego, Inc. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| CVS HealthWoonsocket Prescription Center, IncorporatedCocaine/cocaine metabolite IVD, reagent | 423094 | Woonsocket Prescription Center, Incorporated | Cocaine/cocaine metabolite IVD, reagent |
| DOA 1 PANEL TESTRapid Diagnostics IncMultiple drugs of abuse IVD, kit, rapid ICT, clinical | 07RD7060-01 | Rapid Diagnostics Inc | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| DOA 6 PANEL TESTRapid Diagnostics IncMultiple drugs of abuse IVD, kit, rapid ICT, clinical | 07RD7065-03 | Rapid Diagnostics Inc | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| eCUP™Escreen, Inc.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | E&I eCUP™ | Escreen, Inc. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| First Sign®Hemosure Inc.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | FSCDIPMT-25 | Hemosure Inc. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| FIRST SIGN®Hemosure Inc.Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical | FSCWTH-25 | Hemosure Inc. | Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical |
| INSTANT-VIEW Morphine (2000) Urine Dip Cassette TestAlfa Scientific Designs, Inc.Opiate/opiate metabolite IVD, kit, rapid ICT, clinical | 03-3092QW | Alfa Scientific Designs, Inc. | Opiate/opiate metabolite IVD, kit, rapid ICT, clinical |
| INSTANT-VIEW Morphine/Opiates (2000) Urine Dip-Strip TestAlfa Scientific Designs, Inc.Opiate/opiate metabolite IVD, kit, rapid ICT, clinical | 03-3097 | Alfa Scientific Designs, Inc. | Opiate/opiate metabolite IVD, kit, rapid ICT, clinical |
| iScreen™Instant Technologies, Inc.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | DBZ-114 | Instant Technologies, Inc. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| MD DugScreenMedical Disposables CorpMultiple drugs of abuse IVD, kit, rapid ICT, clinical | M-DOA-1104 | Medical Disposables Corp | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| MD DugScreenMedical Disposables CorpMultiple drugs of abuse IVD, kit, rapid ICT, clinical | MDC-654AD | Medical Disposables Corp | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |