Precision
2 catalogue numbers from PRES-SAL-3114A, listed by American Screening, L.L.C., under Test, Amphetamine, Over The Counter. 16 manufacturers in China are registered for this product code.
16manufacturers in China registered for this device type
2catalogue numbers in this listing
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, Amphetamine, Over The Counter
Record
| Listed by | American Screening, L.L.C. |
|---|---|
| FDA product code | NFT |
| Device type | Test, Amphetamine, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3100 |
| 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 |
|---|---|---|
| PRES-SAL-3114A | In distribution | |
| PRES-SAL-17104 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discover Plus | American Screening, L.L.C. | 59 |
| Precision DX | American Screening, L.L.C. | 42 |
| Discover | American Screening, L.L.C. | 32 |
| iScreen™ | Instant Technologies, Inc. | 31 |
| Reveal | American Screening, L.L.C. | 26 |
| Prime Screen | Wondfo USA Co., Ltd. | 20 |
| U-Catch | Shenzhen Bioeasy Biotechnology Co., Ltd. | 19 |
| SAFElife™ | Wondfo USA Co., Ltd. | 18 |
| DrugTect Multi-Drug Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 17 |
| Precision Plus | American Screening, L.L.C. | 12 |
| Rapid Response | Btnx Inc. | 11 |
| OneScreen | American Screening, L.L.C. | 9 |
Showing 12 of 113. All products under Test, Amphetamine, 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.