A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of a specific amphetamine in a clinical specimen within a short period, relative to standard laboratory testing procedures, usi
| Company | Devices | Share |
|---|---|---|
| Guangzhou Decheng Biotechnology Co., Ltd | 35 | 42% |
| Princeton Biomeditech Corporation | 10 | 12% |
| Hangzhou Alltest Biotech Co., Ltd. | 7 | 8% |
| Assure Tech. (Hangzhou) Co., Ltd. | 6 | 7% |
| Carolina Liquid Chemistries Corporation | 5 | 6% |
| Alfa Scientific Designs, Inc. | 5 | 6% |
| Mercedes Medical, Llc | 3 | 4% |
| Bio-Rad Laboratories, Inc. | 3 | 4% |
| Hemosure Inc. | 2 | 2% |
| Germaine Laboratories, Inc | 2 | 2% |
| W.H.P.M. Inc. | 1 | 1% |
| Rapid 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 |
|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | 30 |
| PUX | Test, Amphetamine, Employment And Insurance Testing, Exempt | 24 |
| PUY | Test, Barbiturate, Employment And Insurance Testing, Exempt | 24 |
| PVA | Test, Cocaine And Cocaine Metabolite, Employment And Insuran | 24 |
| PVJ | Test, Cannabinoid, Employment And Insurance Testing, Exempt | 24 |
| PVE | Test, Methadone, Employment And Insurance Testing, Exempt | 24 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
83 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Amphetamine-specific IVD, kit, rapid ICT, clinical", from 15 companies. The largest labeler is Guangzhou Decheng Biotechnology Co., Ltd with 42% of records.
DKZ (Enzyme Immunoassay, Amphetamine), PUX (Test, Amphetamine, Employment And Insurance Testing, Exempt), PUY (Test, Barbiturate, Employment And Insurance Testing, Exempt), PVA (Test, Cocaine And Cocaine Metabolite, Employment And Insuran)
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.