DrugConfirm
14 Drugs Tested Home Drug Test
17manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (8), Guangdong (4), Beijing (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Core Technology Co., Ltd. | Changping District | Beijing | Contract manufacturer | 14 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou | Guangdong | Complaint-file establishment | 35 |
| Eterbio, Inc. | Zhuhai | Guangdong | Manufacturer | 29 |
| Safecare Biotech(Hangzhou)Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 22 |
Showing 12 of 17. All 17 manufacturers in China registered for Test, Methadone, Over The Counter
Record
| Listed by | Confirm Biosciences LLC, United States |
|---|---|
| FDA product code | PTG |
| Device type | Test, Methadone, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3620 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| Record published | 2022-10-24 |
| Record revised | 2022-12-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CB-DC-14PanelOTC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discover Plus | American Screening, L.L.C. | 36 |
| Precision DX | American Screening, L.L.C. | 23 |
| Discover | American Screening, L.L.C. | 19 |
| Precision Plus | American Screening, L.L.C. | 15 |
| OneScreen | American Screening, L.L.C. | 14 |
| UScreen® | Instant Technologies, Inc. | 6 |
| Reveal | American Screening, L.L.C. | 5 |
| Precision | American Screening, L.L.C. | 2 |
| Amazewell | Guangzhou Decheng Biotechnology Co., Ltd. | 2 |
| Alltest EDDP300 Rapid Test Panel (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 1 |
| Alltest EDDP300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 1 |
| AssureTech Quick Cup Test | Assure Tech. (Hangzhou) Co., Ltd. | 1 |
Showing 12 of 27. All products under Test, Methadone, Over The Counter
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.