A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of fentanyl in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunoch
| Company | Devices | Share |
|---|---|---|
| Hangzhou Alltest Biotech Co., Ltd. | 20 | 40% |
| Wondfo Usa Co., Ltd. | 14 | 28% |
| Aceso Laboratories Inc. | 3 | 6% |
| Btnx Inc | 3 | 6% |
| Shenzhen Superbio Technology Co., Ltd. | 2 | 4% |
| Eterbio, Inc. | 1 | 2% |
| Safecare Biotech (Hangzhou) Co., Ltd. | 1 | 2% |
| Hysen Inc. | 1 | 2% |
| Diagnostic Automation, Inc. | 1 | 2% |
| Instant Technologies, Inc. | 1 | 2% |
| Carolina Liquid Chemistries Corporation | 1 | 2% |
| Germaine Laboratories, Inc | 1 | 2% |
Company = labeler of record on GUDID. 13 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 |
|---|---|---|
| NGL | Test, Opiates, Over The Counter | 27 |
| DJG | Enzyme Immunoassay, Opiates | 23 |
| DJG | Enzyme immunoassay, opiates | 1 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
50 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fentanyl IVD, kit, rapid ICT, clinical", from 13 companies. The largest labeler is Hangzhou Alltest Biotech Co., Ltd. with 40% of records.
NGL (Test, Opiates, Over The Counter), DJG (Enzyme Immunoassay, Opiates), DJG (Enzyme immunoassay, opiates)
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.