First Check
Catalogue number 2 Drug Test, listed by First Check Diagnostic Corp., under Test, Cocaine And Cocaine Metabolites, 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, Cocaine And Cocaine Metabolites, Over The Counter
Record
| Listed by | First Check Diagnostic Corp. |
|---|---|
| FDA product code | NFY |
| Device type | Test, Cocaine And Cocaine Metabolites, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3250 |
| 510(k) | K052115 |
| Record published | 2016-06-30 |
| Record revised | 2022-06-10 (version 7) |
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 |
| Storage | Storage environment temperature 40 to 86 °F |
| Distribution end date | 2021-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2 Drug Test | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discover | American Screening, L.L.C. | 36 |
| Discover Plus | American Screening, L.L.C. | 33 |
| Precision DX | American Screening, L.L.C. | 26 |
| Precision Plus | American Screening, L.L.C. | 12 |
| Reveal | American Screening, L.L.C. | 12 |
| Rapid Response | Btnx Inc. | 8 |
| OneScreen | American Screening, L.L.C. | 8 |
| Discover Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 5 |
| DrugConfirm | Confirm Biosciences LLC | 2 |
| Rite Aid | Rite AID Corporation | 2 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 2 |
| AmediCheck Instant Test Cup | Ameditech, Inc. | 2 |
Showing 12 of 42. All products under Test, Cocaine And Cocaine Metabolites, Over The Counter
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ameditech, Inc. | 510(k) number | 2020-08-18 | Class II | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. | 28,525 | 2024-09-30 |
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.