Precision DX
13 catalogue numbers from PREDX-CUP-764N, listed by American Screening, L.L.C., under Test, Tricyclic Antidepressants, Over The Counter. 16 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Zhejiang (8), Guangdong (4), Tianjin (1). 3 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 |
| 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 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 16. All 16 manufacturers in China registered for Test, Tricyclic Antidepressants, Over The Counter
Record
| Listed by | American Screening, L.L.C. |
|---|---|
| FDA product code | QAW |
| Device type | Test, Tricyclic Antidepressants, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3910 |
| 510(k) | K180349 |
| Record published | 2022-11-11 |
| Record revised | 2024-10-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PREDX-CUP-764N | In distribution | |
| PREDX-CUP-384N | In distribution | |
| PREDXDUD20124M | In distribution | |
| PREDXOSAL17123 | In distribution | |
| PREDXOSAL165I | In distribution | |
| PREDX-ALCO | In distribution | |
| PREDXOSAL1710I | In distribution | |
| PREDX-ADT-264 | In distribution | |
| PREDX-DOA9124N | In distribution | |
| PREDX-U-VACT | In distribution | |
| PREDX-ADT-264 | In distribution | |
| PREDX-ADT-EDDP | In distribution | |
| PREDX-MDCT-U23 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discover Plus | American Screening, L.L.C. | 31 |
| Discover | American Screening, L.L.C. | 27 |
| OneScreen | American Screening, L.L.C. | 13 |
| Precision | American Screening, L.L.C. | 5 |
| Precision Plus | American Screening, L.L.C. | 5 |
| Reveal | American Screening, L.L.C. | 5 |
| UScreen® | Instant Technologies, Inc. | 2 |
| T-Cup® Compact | Instant Technologies, Inc. | 2 |
| Alltest TCA1000 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 1 |
| Alltest TCA1000 Home Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 1 |
| Alltest TCA1000 Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 1 |
| mLife Rapid Drug Test | Mlife Diagnostics LLC | 1 |
Showing 12 of 16. All products under Test, Tricyclic Antidepressants, 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.