One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein (AFP) in a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Diagnostic Biosystems, Inc. | 13 | 24% |
| Bio Sb, Inc. | 12 | 22% |
| Cell Marque Corporation | 11 | 20% |
| Leica Biosystems Newcastle Ltd | 4 | 7% |
| Epitomics Inc. | 4 | 7% |
| Agilent Technologies Singapore Pte Ltd | 3 | 6% |
| Slmp, Llc | 3 | 6% |
| Biocare Medical Llc | 2 | 4% |
| Biogenex Laboratories | 1 | 2% |
| Sakura Finetek U.S.A., Inc. | 1 | 2% |
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 | 49 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 6 |
Use these as the dimensions to specify in a tender line.
54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Alpha-fetoprotein (AFP) IVD, antibody", from 10 companies. The largest labeler is Diagnostic Biosystems, Inc. with 24% of records.
NJT (Immunohistochemistry Reagents And Kits), 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.