A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Bio-Rad Laboratories, Inc. | 60 | 61% |
| Horiba Abx Sas | 9 | 9% |
| Beckman Coulter, Inc. | 9 | 9% |
| Lgc Clinical Diagnostics, Inc. | 7 | 7% |
| Randox Laboratories Limited | 6 | 6% |
| Ortho-Clinical Diagnostics, Inc. | 6 | 6% |
| Aalto Scientific | 2 | 2% |
Company = labeler of record on GUDID. 7 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 |
|---|---|---|
| JJY | Multi-analyte controls, all kinds (assayed) | 60 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 32 |
| JIT | Calibrator, secondary | 3 |
| JJX | Single (specified) analyte controls (assayed and unassayed) | 3 |
Use these as the dimensions to specify in a tender line.
99 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple clinical chemistry protein IVD, control", from 7 companies. The largest labeler is Bio-Rad Laboratories, Inc. with 61% of records.
JJY (Multi-analyte controls, all kinds (assayed)), JJY (Multi-Analyte Controls, All Kinds (Assayed)), JIT (Calibrator, secondary), JJX (Single (specified) analyte controls (assayed and unassayed))
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.