A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical spec
| Company | Devices | Share |
|---|---|---|
| Utak Laboratories, Inc. | 1,322 | 67% |
| Techno-Path Manufacturing Limited | 209 | 11% |
| Bio-Rad Laboratories, Inc. | 82 | 4% |
| Randox Laboratories Limited | 73 | 4% |
| Roche Diagnostics Gmbh | 63 | 3% |
| Microgenics Corporation | 59 | 3% |
| Cliniqa Corporation | 28 | 1% |
| Aalto Scientific | 27 | 1% |
| Lgc Clinical Diagnostics, Inc. | 23 | 1% |
| Vitalscientific | 10 | 1% |
| Infrared Laboratory Systems Llc | 6 | 0% |
| Immunalysis Corp | 6 | 0% |
Company = labeler of record on GUDID. 33 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 | 1,322 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 392 |
| OHQ | Multi-Analyte Controls Unassayed | 192 |
| JJY | Multi-analyte controls, all kinds (assayed) | 80 |
| JJX | Single (specified) analyte controls (assayed and unassayed) | 51 |
| OHQ | Multi-analyte controls unassayed | 16 |
Use these as the dimensions to specify in a tender line.
1,963 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple-type clinical chemistry analyte profile IVD, control", from 33 companies. The largest labeler is Utak Laboratories, Inc. with 67% of records.
LAS (Drug Specific Control Materials), JJY (Multi-Analyte Controls, All Kinds (Assayed)), OHQ (Multi-Analyte Controls Unassayed), 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.