One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of Ki67 antigen in a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Biocare Medical Llc | 18 | 16% |
| Bio Sb, Inc. | 18 | 16% |
| Diagnostic Biosystems, Inc. | 16 | 14% |
| Biogenex Laboratories | 16 | 14% |
| Fuzhou Maixin Biotech Co., Ltd. | 8 | 7% |
| Leica Biosystems Newcastle Ltd | 8 | 7% |
| Agilent Technologies Singapore Pte Ltd | 7 | 6% |
| Cell Marque Corporation | 6 | 5% |
| Sakura Finetek U.S.A., Inc. | 6 | 5% |
| Slmp, Llc | 4 | 4% |
| Epitomics Inc. | 4 | 4% |
| Ventana Medical Systems, Inc. | 1 | 1% |
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 | 97 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 19 |
| MVU | Reagents, specific, analyte | 4 |
Use these as the dimensions to specify in a tender line.
114 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ki67 antigen IVD, antibody", from 14 companies. The largest labeler is Biocare Medical Llc with 16% of records.
NJT (Immunohistochemistry Reagents And Kits), NJT (IMMUNOHISTOCHEMISTRY REAGENTS AND KITS), MVU (Reagents, specific, analyte)
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.