A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of opiate and/or opiate metabolites in a clinical specimen within a short period, relative to standard laboratory testing proce
| Company | Devices | Share |
|---|---|---|
| Ucp Biosciences, Inc. | 17 | 23% |
| Assure Tech. (Hangzhou) Co., Ltd. | 12 | 16% |
| Alfa Scientific Designs, Inc. | 11 | 15% |
| Guangzhou Decheng Biotechnology Co., Ltd | 9 | 12% |
| Express Diagnostic Int'L, Inc. | 5 | 7% |
| Germaine Laboratories, Inc | 4 | 5% |
| Instant Technologies, Inc. | 3 | 4% |
| Bio-Rad Laboratories, Inc. | 3 | 4% |
| Rapid Diagnostics Inc | 2 | 3% |
| Jant Pharmacal Corporation | 2 | 3% |
| Princeton Biomeditech Corporation | 2 | 3% |
| Siemens Healthcare Diagnostics Inc. | 1 | 1% |
Company = labeler of record on GUDID. 15 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 |
|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 61 |
| NGL | Test, Opiates, Over The Counter | 10 |
| NFT | Test, Amphetamine, Over The Counter | 9 |
| PTH | Test, Barbiturate, Over The Counter | 9 |
| NFV | Test, Benzodiazepine, Over The Counter | 9 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | 9 |
Use these as the dimensions to specify in a tender line.
74 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Opiate/opiate metabolite IVD, kit, rapid ICT, clinical", from 15 companies. The largest labeler is Ucp Biosciences, Inc. with 23% of records.
DJG (Enzyme Immunoassay, Opiates), NGL (Test, Opiates, Over The Counter), NFT (Test, Amphetamine, Over The Counter), PTH (Test, Barbiturate, 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.