UScreen®
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (COC/MOP/AMP/MET/BAR/BZO/BUP/PCP/MDMA/MTD/OXY/TCA)
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 | Instant Technologies, Inc. |
|---|---|
| FDA product code | QAW |
| Device type | Test, Tricyclic Antidepressants, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3910 |
| 510(k) | K182701 |
| Record published | 2021-01-13 |
| Record revised | 2025-06-10 (version 8) |
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 |
| Distribution end date | 2025-06-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| USSCupA-12NTCLIA | In distribution | |
| USSCupA-12CLIA | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discover Plus | American Screening, L.L.C. | 31 |
| Discover | American Screening, L.L.C. | 27 |
| Precision DX | American Screening, L.L.C. | 13 |
| 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 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | UDI-DI | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | a. unk b. 6 c. 1 d. 1 e. 67 f. 1 g. 10 h. 51 i. 27 j. 105 k. |
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.