A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of cocaine and/or cocaine metabolites in a clinical specimen within a short period, relative to standard laboratory testing pro
| Company | Devices | Share |
|---|---|---|
| Guangzhou Decheng Biotechnology Co., Ltd | 12 | 21% |
| Hangzhou Alltest Biotech Co., Ltd. | 7 | 12% |
| Alfa Scientific Designs, Inc. | 6 | 11% |
| Princeton Biomeditech Corporation | 6 | 11% |
| Assure Tech. (Hangzhou) Co., Ltd. | 4 | 7% |
| Ucp Biosciences, Inc. | 4 | 7% |
| Hemosure Inc. | 2 | 4% |
| Rapid Diagnostics Inc | 2 | 4% |
| Express Diagnostic Int'L, Inc. | 2 | 4% |
| Safecare Biotech (Hangzhou) Co., Ltd. | 1 | 2% |
| Idun Solutions Llc | 1 | 2% |
| Bio-Rad Laboratories, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 41 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | 20 |
| DJG | Enzyme Immunoassay, Opiates | 14 |
| NGL | Test, Opiates, Over The Counter | 12 |
| NFW | Test, Cannabinoid, Over The Counter | 12 |
| PTH | Test, Barbiturate, Over The Counter | 11 |
Use these as the dimensions to specify in a tender line.
56 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical", from 20 companies. The largest labeler is Guangzhou Decheng Biotechnology Co., Ltd with 21% of records.
DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), NFY (Test, Cocaine And Cocaine Metabolites, Over The Counter), DJG (Enzyme Immunoassay, Opiates), NGL (Test, Opiates, Over The Counter)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.