A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Lin-Zhi International, Inc. | 24 | 36% |
| Immunalysis Corp | 12 | 18% |
| Horiba Instruments Incorporated | 8 | 12% |
| Ark Diagnostics Inc | 7 | 10% |
| Microgenics Corporation | 6 | 9% |
| Abbott Laboratories | 6 | 9% |
| Beckman Coulter, Inc. | 2 | 3% |
| American Bio Medica Corporation | 2 | 3% |
Company = labeler of record on GUDID. 8 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 |
|---|---|---|
| DLJ | Calibrators, Drug Specific | 52 |
| DJG | Enzyme Immunoassay, Opiates | 4 |
| DKB | Calibrators, drug mixture | 4 |
| DKB | CALIBRATORS, DRUG MIXTURE | 4 |
| DLJ | Calibrators, drug specific | 2 |
| DKG | Plate, Cellulose, Tlc | 2 |
Use these as the dimensions to specify in a tender line.
67 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Opiate/opiate metabolite IVD, calibrator", from 8 companies. The largest labeler is Lin-Zhi International, Inc. with 36% of records.
DLJ (Calibrators, Drug Specific), DJG (Enzyme Immunoassay, Opiates), DKB (Calibrators, drug mixture), DKB (CALIBRATORS, DRUG MIXTURE)
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.
Add opiate/opiate metabolite ivd, calibrator to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.
Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.
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.