An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) faci
| Company | Devices | Share |
|---|---|---|
| Abbott Gmbh | 291 | 46% |
| Abbott Laboratories | 75 | 12% |
| Abbott Molecular Inc. | 45 | 7% |
| Hologic, Inc. | 31 | 5% |
| Cellavision Ab | 20 | 3% |
| Medis Medical Imaging Systems B.V. | 19 | 3% |
| Becton, Dickinson And Company | 17 | 3% |
| Beckman Coulter, Inc. | 16 | 3% |
| Exact Sciences Corporation | 11 | 2% |
| Abbott Srl | 11 | 2% |
| Life Technologies Holdings Pte. Ltd. | 11 | 2% |
| Leica Biosystems Richmond, Inc. | 9 | 1% |
Company = labeler of record on GUDID. 40 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 |
|---|---|---|
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US | 343 |
| JOY | DEVICE, AUTOMATED CELL-LOCATING | 42 |
| JJE | Analyzer, chemistry (photometric, discrete), for clinical us | 32 |
| JOY | Device, Automated Cell-Locating | 27 |
| OYE | Flow cytometric reagents and accessories. | 26 |
| GKZ | Counter, differential cell | 26 |
Use these as the dimensions to specify in a tender line.
637 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Laboratory instrument/analyser application software IVD", from 40 companies. The largest labeler is Abbott Gmbh with 46% of records.
JJE (ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US), JOY (DEVICE, AUTOMATED CELL-LOCATING), JJE (Analyzer, chemistry (photometric, discrete), for clinical us), JOY (Device, Automated Cell-Locating)
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.