A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together
| Company | Devices | Share |
|---|---|---|
| Omnis Health | 26 | 37% |
| Bionime Corporation | 18 | 26% |
| Medline Industries, Inc. | 6 | 9% |
| Biotest Medical Corporation | 5 | 7% |
| Simple Diagnostics Inc | 5 | 7% |
| I-Sens, Inc. | 4 | 6% |
| All Medicus Co.,Ltd. | 3 | 4% |
| Prodigy Diabetes Care, Llc | 1 | 1% |
| H. E. Butt Grocery Company | 1 | 1% |
| Wal-Mart Stores, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 10 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 |
|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 52 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 33 |
| LFR | Glucose Dehydrogenase, Glucose | 24 |
| CGA | Glucose Oxidase, Glucose | 23 |
| NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 4 |
| JJX | Single (specified) analyte controls (assayed and unassayed) | 3 |
Use these as the dimensions to specify in a tender line.
70 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Home-use/point-of-care blood glucose monitoring system IVD", from 10 companies. The largest labeler is Omnis Health with 37% of records.
NBW (System, Test, Blood Glucose, Over The Counter), JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), LFR (Glucose Dehydrogenase, Glucose), CGA (Glucose Oxidase, 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.