UScreen®
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR/pH/OX/SG/Ni) 11 Panel Drug Test Cup(AMP500/BAR300/BZO300/BUP10/THC50/COC150/MTD300/MET500/MDMA500/MOP300/OXY100)
16manufacturers in China registered for this device type
1catalogue number
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, Barbiturate, Over The Counter
Record
| Listed by | Instant Technologies, Inc. |
|---|---|
| FDA product code | PTH |
| Device type | Test, Barbiturate, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3150 |
| 510(k) | K182701 |
| Record published | 2021-05-25 |
| Record revised | 2024-10-14 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| USSCupA-11CLIALC | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discover | American Screening, L.L.C. | 28 |
| Discover Plus | American Screening, L.L.C. | 27 |
| Precision DX | American Screening, L.L.C. | 24 |
| OneScreen | American Screening, L.L.C. | 11 |
| Reveal | American Screening, L.L.C. | 7 |
| Precision Plus | American Screening, L.L.C. | 5 |
| Amazewell | Guangzhou Decheng Biotechnology Co., Ltd. | 4 |
| Hysen Multiple Drugs Test Cup | Hysen Inc | 3 |
| Noble | Guangzhou Decheng Biotechnology Co., Ltd. | 3 |
| Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 3 |
| Precision | American Screening, L.L.C. | 3 |
| VeriCheck Drug Test Dip | Verify Diagnostics Inc | 3 |
Showing 12 of 42. All products under Test, Barbiturate, 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.