A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Tyson Bioresearch Inc. | 21 | 13% |
| Trividia Health, Inc. | 15 | 9% |
| Arkray Usa, Inc. | 15 | 9% |
| Home Aide Diagnostics, Inc. | 11 | 7% |
| Fora Care Inc. | 9 | 5% |
| Nova Biomedical Corporation | 8 | 5% |
| Roche Diagnostics Operations, Inc. | 8 | 5% |
| U.S. Diagnostics Inc. | 6 | 4% |
| Eps Bio Technology Corp. | 6 | 4% |
| Biotest Medical Corporation | 5 | 3% |
| Agamatrix, Inc. | 5 | 3% |
| Eurotrol B.V. | 5 | 3% |
Company = labeler of record on GUDID. 42 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 |
|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 132 |
| NBW | System, Test, Blood Glucose, Over The Counter | 76 |
| CGA | Glucose Oxidase, Glucose | 15 |
| LFR | Glucose Dehydrogenase, Glucose | 8 |
| JJX | Single (specified) analyte controls (assayed and unassayed) | 7 |
| CGA | GLUCOSE OXIDASE, GLUCOSE | 3 |
Use these as the dimensions to specify in a tender line.
164 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Glucose IVD, control", from 42 companies. The largest labeler is Tyson Bioresearch Inc. with 13% of records.
JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), NBW (System, Test, Blood Glucose, Over The Counter), CGA (Glucose Oxidase, Glucose), LFR (Glucose Dehydrogenase, Glucose)
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.