An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., protein, drug, hormone, microbial toxin) in a clinical spe
| Company | Devices | Share |
|---|---|---|
| Abbott Laboratories | 21 | 26% |
| Siemens Healthcare Diagnostics Inc. | 9 | 11% |
| Shenzhen Yhlo Biotech Co., Ltd. | 8 | 10% |
| Roche Diagnostics Gmbh | 7 | 9% |
| Tosoh Corporation | 6 | 8% |
| Qualigen Inc. | 5 | 6% |
| Ortho-Clinical Diagnostics, Inc. | 5 | 6% |
| Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2 | 2% |
| Monobind, Inc. | 2 | 2% |
| Beckman Coulter, Inc. | 2 | 2% |
| Stratec Consumables Gmbh | 2 | 2% |
| Diasorin Spa | 2 | 2% |
Company = labeler of record on GUDID. 21 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 | 39 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Us | 23 |
| MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | 6 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 5 |
| MZA | Test, equipment, automated bloodborne pathogen | 4 |
| JJE | Analyzer, chemistry (photometric, discrete), for clinical us | 3 |
Use these as the dimensions to specify in a tender line.
80 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Chemiluminescent immunoassay analyser IVD", from 21 companies. The largest labeler is Abbott Laboratories with 26% of records.
JJE (ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US), JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Us), MZA (TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN), JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use)
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.