One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of human epidermal growth factor receptor 2 (HER2) protein, also known as HER2 or neu oncoprotein, i
| Company | Devices | Share |
|---|---|---|
| Bio Sb, Inc. | 24 | 25% |
| Diagnostic Biosystems, Inc. | 20 | 21% |
| Biocare Medical Llc | 15 | 16% |
| Biogenex Laboratories | 13 | 14% |
| Leica Biosystems Newcastle Ltd | 6 | 6% |
| Fuzhou Maixin Biotech Co., Ltd. | 4 | 4% |
| Epitomics Inc. | 4 | 4% |
| Sakura Finetek U.S.A., Inc. | 4 | 4% |
| Ventana Medical Systems, Inc. | 2 | 2% |
| Becton, Dickinson And Company | 2 | 2% |
| Agilent Technologies Singapore Pte Ltd | 1 | 1% |
| Novodiax, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 12 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 | 57 |
| NJT | Immunohistochemistry Reagents And Kits | 34 |
| MVU | Reagents, specific, analyte | 5 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 1 |
| MVC | SYSTEM, TEST, HER-2/NEU, IHC | 1 |
| MVC | System, Test, Her-2/Neu, Ihc | 1 |
Use these as the dimensions to specify in a tender line.
96 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody", from 12 companies. The largest labeler is Bio Sb, Inc. with 25% of records.
MVU (Reagents, Specific, Analyte), NJT (Immunohistochemistry Reagents And Kits), MVU (Reagents, specific, analyte), NJT (IMMUNOHISTOCHEMISTRY REAGENTS AND KITS)
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.