A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen, using an enzyme immunoassay (EIA) method.
| Company | Devices | Share |
|---|---|---|
| Microgenics Corporation | 15 | 24% |
| Lin-Zhi International, Inc. | 11 | 17% |
| Siemens Healthcare Diagnostics Inc. | 8 | 13% |
| Immunalysis Corp | 8 | 13% |
| Carolina Liquid Chemistries Corporation | 7 | 11% |
| Ark Diagnostics Inc | 5 | 8% |
| Horiba Instruments Incorporated | 4 | 6% |
| Abbott Laboratories | 2 | 3% |
| Beckman Coulter, Inc. | 2 | 3% |
| Ortho-Clinical Diagnostics, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 10 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 | 46 |
| DJG | ENZYME IMMUNOASSAY, OPIATES | 18 |
| PVH | Test, Opiates, Employment And Insurance Testing, Exempt | 3 |
| DJG | Enzyme immunoassay, opiates | 3 |
| PVH | Test, opiates, employment and insurance testing, exempt | 2 |
| LAS | DRUG SPECIFIC CONTROL MATERIALS | 2 |
Use these as the dimensions to specify in a tender line.
63 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, enzyme immunoassay (EIA)", from 10 companies. The largest labeler is Microgenics Corporation with 24% of records.
DJG (Enzyme Immunoassay, Opiates), DJG (ENZYME IMMUNOASSAY, OPIATES), PVH (Test, Opiates, Employment And Insurance Testing, Exempt), 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.