Rapid Response
D12.49-1VAF Internal Code: D12.49-1VAF-TU - OXY100 BZO300 MOR300 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 FYL1+ OXI/CRE/PH
16manufacturers in China registered for this device type
8catalogue 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, Cocaine And Cocaine Metabolites, Over The Counter
Record
| Listed by | Btnx Inc., Canada |
|---|---|
| FDA product code | NFY |
| Device type | Test, Cocaine And Cocaine Metabolites, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3250 |
| Establishment | Repacker / relabeller, Private-label distributor, Complaint-file establishment, Exporter |
| 510(k) | K180349 |
| Record published | 2020-01-09 |
| Record revised | 2023-04-20 (version 4) |
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 |
| Packaging | Case of 100 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| D10.32-1V | In distribution | ||
| D3.36-1V | In distribution | ||
| D6.6.2-1V | In distribution | ||
| D12.5-1VF | 25 | In distribution | |
| D10.32-1VF | 25 | In distribution | |
| D12.49-1VAF | 25 | In distribution | |
| D10.3.1-1V | In distribution | ||
| D12.49-1VAF | 25 | In distribution |
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 |
| 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 |
| Identify Diagnostics Multi-Drug Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2 |
Showing 12 of 42. All products under Test, Cocaine And Cocaine Metabolites, 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.