One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of p16 antigen in a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Diagnostic Biosystems, Inc. | 19 | 26% |
| Bio Sb, Inc. | 18 | 25% |
| Biogenex Laboratories | 11 | 15% |
| Biocare Medical Llc | 9 | 12% |
| Ventana Medical Systems, Inc. | 5 | 7% |
| Fuzhou Maixin Biotech Co., Ltd. | 4 | 5% |
| Slmp, Llc | 3 | 4% |
| Leica Biosystems Newcastle Ltd | 2 | 3% |
| Agilent Technologies Singapore Pte Ltd | 1 | 1% |
| Sakura Finetek U.S.A., Inc. | 1 | 1% |
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 |
|---|---|---|
| NJT | Immunohistochemistry Reagents And Kits | 57 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 9 |
| MVU | Reagents, Specific, Analyte | 5 |
| PRB | Cervical intraepithelial neoplasia (CIN) test system | 2 |
| MVU | Reagents, specific, analyte | 1 |
Use these as the dimensions to specify in a tender line.
73 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "p16 antigen IVD, antibody", from 10 companies. The largest labeler is Diagnostic Biosystems, Inc. with 26% of records.
NJT (Immunohistochemistry Reagents And Kits), NJT (IMMUNOHISTOCHEMISTRY REAGENTS AND KITS), MVU (Reagents, Specific, Analyte), PRB (Cervical intraepithelial neoplasia (CIN) test system)
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.