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| Product | Model | Company | Device type |
|---|---|---|---|
| MGC HEALTHGuangzhou Decheng Biotechnology Co., LTDCocaine/cocaine metabolite IVD, kit, rapid ICT, clinical | 2T | Guangzhou Decheng Biotechnology Co., LTD | Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical |
| Multiple drugs of abuse IVD, kit, rapid ICT, clinicalAlere San Diego, Inc.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | DPP-114 | Alere San Diego, Inc. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| Nano-Check™ OPI TestNano-Ditech CorporationMultiple drugs of abuse IVD, kit, rapid ICT, clinical | AD4183 | Nano-Ditech Corporation | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| NexScreen Drug Screen CupNexscreen, LLCMultiple drugs of abuse IVD, kit, rapid ICT, clinical | ND-60511N | Nexscreen, LLC | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| One Step COCAINE (COC) Home Rapid Test DipstickHangzhou 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 |
| Onsite DrugScreenMedical Disposables CorpMultiple drugs of abuse IVD, kit, rapid ICT, clinical | ODTC-6125 | Medical Disposables Corp | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| Platelet PGDprime Reagent 2Verax Biomedical IncorporatedLipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical | P01214 | Verax Biomedical Incorporated | Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical |
| PRIME SCREEN®Wondfo USA Co., Ltd.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | DSODOA-666EUO-5BX-A | Wondfo USA Co., Ltd. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| PrimeScreenWondfo USA Co., Ltd.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | DODOA-256-EUO-25BX-B | Wondfo USA Co., Ltd. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| QMedix™Diagnostic Automation, Inc.Benzodiazepine group IVD, kit, rapid ICT, clinical | DACD121061-1-19 | Diagnostic Automation, Inc. | Benzodiazepine group IVD, kit, rapid ICT, clinical |
| QuickProfile™ Methamphetamine Test CardLumiquick Diagnostics, Inc.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | 07RD7006 | Lumiquick Diagnostics, Inc. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| RAPID DIAGNOSTICS BARBITURATE TEST STRIP KIT (50)Rapid Diagnostics IncBarbiturate IVD, kit, rapid ICT, clinical | 07RD8015 | Rapid Diagnostics Inc | Barbiturate IVD, kit, rapid ICT, clinical |
| Rapid ResponseBTNX IncMultiple drugs of abuse IVD, kit, rapid ICT, clinical | MOP-1C3-40 | BTNX Inc | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| Rapid ResponseBTNX IncMultiple drugs of abuse IVD, kit, rapid ICT, clinical | THC-1S13-100 | BTNX Inc | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| SAFElife™Wondfo USA Co., Ltd.Fentanyl IVD, kit, rapid ICT, clinical | WFTY-OTC1-10BX | Wondfo USA Co., Ltd. | Fentanyl IVD, kit, rapid ICT, clinical |
| SAFElife™Wondfo USA Co., Ltd.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | DCDOA-564-5BX-A | Wondfo USA Co., Ltd. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| STATSWAB®Micro Distributing, L.cMultiple drugs of abuse IVD, kit, rapid ICT, clinical | SSB-368 | Micro Distributing, L.c | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| STATSWABII®Micro Distributing, L.cMultiple drugs of abuse IVD, kit, rapid ICT, clinical | SWABII-368 | Micro Distributing, L.c | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| Status DS™ TCA cardPrinceton Biomeditech CorporationTricyclic antidepressant IVD, kit, rapid ICT, clinical | DOA-209-35-01 | Princeton Biomeditech Corporation | Tricyclic antidepressant IVD, kit, rapid ICT, clinical |
| Syva® RapidTest d.a.u.® 3Siemens Healthcare Diagnostics Inc.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | 10445358 | Siemens Healthcare Diagnostics Inc. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| TOX/SeeBio-Rad Laboratories, Inc.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | 194-5204 | Bio-Rad Laboratories, Inc. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| Urine Dip CardInstant Technologies, Inc.Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical | ATS-K2 | Instant Technologies, Inc. | Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical |