A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a c
| Company | Devices | Share |
|---|---|---|
| Utak Laboratories, Inc. | 81 | 69% |
| Chromsystems Instruments + Chemicals Gmbh | 11 | 9% |
| Bio-Rad Laboratories, Inc. | 10 | 8% |
| Ortho-Clinical Diagnostics, Inc. | 8 | 7% |
| Microgenics Corporation | 7 | 6% |
| Roche Diagnostics Gmbh | 1 | 1% |
Company = labeler of record on GUDID. 6 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 |
|---|---|---|
| LAS | Drug Specific Control Materials | 90 |
| DIF | Drug mixture control materials | 18 |
| DIF | Drug Mixture Control Materials | 7 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 |
| JJY | Multi-analyte controls, all kinds (assayed) | 1 |
| NWM | Immunoassay, Anti-Seizure Drug | 1 |
Use these as the dimensions to specify in a tender line.
118 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple-therapy therapeutic drug monitoring IVD, control", from 6 companies. The largest labeler is Utak Laboratories, Inc. with 69% of records.
LAS (Drug Specific Control Materials), DIF (Drug mixture control materials), DIF (Drug Mixture Control Materials), JJY (Multi-Analyte Controls, All Kinds (Assayed))
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.