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 in a clinical specimen. The instrument detects fluorescent marker
| Company | Devices | Share |
|---|---|---|
| Biomerieux Sa | 12 | 23% |
| Phadia Ab | 10 | 19% |
| Wallac Oy | 8 | 15% |
| B.R.A.H.M.S Gmbh | 4 | 8% |
| Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 3 | 6% |
| Sanwa Biotech Limited | 3 | 6% |
| Bio-Rad Laboratories, Inc. | 3 | 6% |
| Shenzhen Superbio Technology Co., Ltd. | 2 | 4% |
| Shenzhen Yhlo Biotech Co., Ltd. | 1 | 2% |
| Aesku.Systems Gmbh & Co. Kg | 1 | 2% |
| Aesku.Diagnostics Gmbh & Co. Kg | 1 | 2% |
| Euroimmun Medizinische Labordiagnostika Ag | 1 | 2% |
Company = labeler of record on GUDID. 16 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 |
|---|---|---|
| KHO | Fluorometer, For Clinical Use | 19 |
| DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 5 |
| NHX | ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) | 4 |
| PIV | Automated Indirect Immunofluorescence Microscope And Softwar | 4 |
| JZT | Fluorometer | 4 |
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US | 4 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fluorescent immunoassay analyser IVD, laboratory", from 16 companies. The largest labeler is Biomerieux Sa with 23% of records.
KHO (Fluorometer, For Clinical Use), DHB (SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL), NHX (ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)), PIV (Automated Indirect Immunofluorescence Microscope And Softwar)
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.