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| Product | Model | Company | Device type |
|---|---|---|---|
| AlltestHangzhou AllTest Biotech Co., Ltd.Fentanyl IVD, kit, rapid ICT, clinical | DFY-A102H | Hangzhou AllTest Biotech Co., Ltd. | Fentanyl IVD, kit, rapid ICT, clinical |
| Alltest BAR300 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.Barbiturate IVD, kit, rapid ICT, clinical | 1 | Hangzhou AllTest Biotech Co., Ltd. | Barbiturate IVD, kit, rapid ICT, clinical |
| Alltest COC150 Rapid Test Panel (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 Multi-Drug 14 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | 1 | Hangzhou AllTest Biotech Co., Ltd. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| Alltest Multi-Drug 9 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | 1 | Hangzhou AllTest Biotech Co., Ltd. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| Alltest PCP25 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.Phencyclidine (PCP) IVD, kit, rapid ICT, clinical | 1 | Hangzhou AllTest Biotech Co., Ltd. | Phencyclidine (PCP) IVD, kit, rapid ICT, clinical |
| Alltest PCP25 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.Phencyclidine (PCP) IVD, kit, rapid ICT, clinical | 1 | Hangzhou AllTest Biotech Co., Ltd. | Phencyclidine (PCP) IVD, kit, rapid ICT, clinical |
| Alltest PCP25 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.Phencyclidine (PCP) IVD, kit, rapid ICT, clinical | 1 | Hangzhou AllTest Biotech Co., Ltd. | Phencyclidine (PCP) IVD, kit, rapid ICT, clinical |
| Alltest PCP25 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.Phencyclidine (PCP) IVD, kit, rapid ICT, clinical | 1 | Hangzhou AllTest Biotech Co., Ltd. | Phencyclidine (PCP) IVD, kit, rapid ICT, clinical |
| Alltest TCA1000 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.Nortriptyline IVD, reagent | 1 | Hangzhou AllTest Biotech Co., Ltd. | Nortriptyline IVD, reagent |
| Alltest TCA1000 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.Nortriptyline IVD, reagent | 1 | Hangzhou AllTest Biotech Co., Ltd. | Nortriptyline IVD, reagent |
| Alltest TCA1000 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.Nortriptyline IVD, reagent | 1 | Hangzhou AllTest Biotech Co., Ltd. | Nortriptyline IVD, reagent |
| Alltest TCA1000 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.Nortriptyline IVD, reagent | 1 | Hangzhou AllTest Biotech Co., Ltd. | Nortriptyline IVD, reagent |
| AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co., Ltd.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | 1.0 | Assure Tech. (Hangzhou) Co., Ltd. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| BluRapids™Mercedes Medical, LLCAmphetamine-specific IVD, kit, rapid ICT, clinical | TNR CDOA7125A3 | Mercedes Medical, LLC | Amphetamine-specific IVD, kit, rapid ICT, clinical |
| Care OneAhold U.S.A., Inc.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | 055544 | Ahold U.S.A., Inc. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| CLUNGENEHangzhou Clongene Biotech Co., Ltd.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | DDOA1c07-200308 | Hangzhou Clongene Biotech Co., Ltd. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| DrugTect Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.Multiple drugs of abuse IVD, kit, rapid ICT, clinical | 1 | Hangzhou AllTest Biotech Co., Ltd. | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| MD DrugScreenMedical Disposables CorpMultiple drugs of abuse IVD, kit, rapid ICT, clinical | MDC-3135 | Medical Disposables Corp | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
| Syva® RapidTest d.a.u.® TCASiemens Healthcare Diagnostics Inc.Tricyclic antidepressant IVD, kit, rapid ICT, clinical | 10445355 | Siemens Healthcare Diagnostics Inc. | Tricyclic antidepressant IVD, kit, rapid ICT, clinical |