One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD8 cell marker in a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Biocare Medical Llc | 14 | 13% |
| Becton, Dickinson And Company | 14 | 13% |
| Life Technologies Corporation | 14 | 13% |
| Diagnostic Biosystems, Inc. | 13 | 12% |
| Bio Sb, Inc. | 12 | 11% |
| Cell Marque Corporation | 10 | 9% |
| Agilent Technologies Singapore Pte Ltd | 7 | 7% |
| Fuzhou Maixin Biotech Co., Ltd. | 4 | 4% |
| Leica Biosystems Newcastle Ltd | 4 | 4% |
| Epitomics Inc. | 4 | 4% |
| Sakura Finetek U.S.A., Inc. | 4 | 4% |
| Biogenex Laboratories | 3 | 3% |
Company = labeler of record on GUDID. 14 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 |
|---|---|---|
| NJT | Immunohistochemistry Reagents And Kits | 67 |
| MVU | Reagents, specific, analyte | 30 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 10 |
| GKZ | Counter, differential cell | 1 |
| MVU | REAGENTS,SPECIFIC,ANALYTE | 1 |
Use these as the dimensions to specify in a tender line.
107 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "CD8 cell marker IVD, antibody", from 14 companies. The largest labeler is Biocare Medical Llc with 13% of records.
NJT (Immunohistochemistry Reagents And Kits), MVU (Reagents, specific, analyte), NJT (IMMUNOHISTOCHEMISTRY REAGENTS AND KITS), GKZ (Counter, differential cell)
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.