A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen. The cardiac markers may include B-type natriuretic protein,
| Company | Devices | Share |
|---|---|---|
| Bio-Rad Laboratories, Inc. | 74 | 52% |
| Microgenics Corporation | 17 | 12% |
| Cliniqa Corporation | 12 | 8% |
| More Diagnostics Inc | 8 | 6% |
| Randox Laboratories Limited | 6 | 4% |
| Lgc Clinical Diagnostics, Inc. | 6 | 4% |
| Aalto Scientific | 6 | 4% |
| Quidel Cardiovascular Inc. | 5 | 3% |
| Ortho-Clinical Diagnostics, Inc. | 2 | 1% |
| Princeton Biomeditech Corporation | 2 | 1% |
| Response Biomedical Corp | 2 | 1% |
| Mardx Diagnostics, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 14 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) | 77 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 47 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 4 |
| JJT | ENZYME CONTROLS (ASSAYED AND UNASSAYED) | 3 |
| JHS | DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES | 2 |
| NUK | For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescen | 1 |
Use these as the dimensions to specify in a tender line.
143 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple cardiac marker IVD, control", from 14 companies. The largest labeler is Bio-Rad Laboratories, Inc. with 52% of records.
JJY (Multi-analyte controls, all kinds (assayed)), JJY (Multi-Analyte Controls, All Kinds (Assayed)), JJT (Enzyme Controls (Assayed And Unassayed)), JJT (ENZYME 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.