One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associate
| Company | Devices | Share |
|---|---|---|
| Exbio Praha, A.S. | 237 | 42% |
| Beckman Coulter, Inc. | 120 | 21% |
| Biogenex Laboratories | 70 | 12% |
| Epitomics Inc. | 62 | 11% |
| Bio Sb, Inc. | 54 | 10% |
| Beckman Coulter Ireland Inc. | 12 | 2% |
| Biocare Medical Llc | 7 | 1% |
| Agilent Technologies Singapore Pte Ltd | 1 | 0% |
| Agilent Technologies, Inc. | 1 | 0% |
| Leica Biosystems Newcastle Ltd | 1 | 0% |
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 |
|---|---|---|
| MVU | Reagents, Specific, Analyte | 348 |
| NJT | Immunohistochemistry Reagents And Kits | 146 |
| GKZ | Counter, Differential Cell | 58 |
| PWD | Flow Cytometric Test System For Hematopoietic Neoplasms | 10 |
| MVU | Reagents, specific, analyte | 3 |
| GKZ | Counter, differential cell | 3 |
Use these as the dimensions to specify in a tender line.
565 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple CD cell marker IVD, antibody", from 10 companies. The largest labeler is Exbio Praha, A.S. with 42% of records.
MVU (Reagents, Specific, Analyte), NJT (Immunohistochemistry Reagents And Kits), GKZ (Counter, Differential Cell), PWD (Flow Cytometric Test System For Hematopoietic Neoplasms)
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.