A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.
| Company | Devices | Share |
|---|---|---|
| Richard-Allan Scientific Company | 945 | 63% |
| Bio Sb, Inc. | 362 | 24% |
| Fuzhou Maixin Biotech Co., Ltd. | 48 | 3% |
| Diagnostic Biosystems, Inc. | 44 | 3% |
| Biocare Medical Llc | 35 | 2% |
| Biogenex Laboratories | 30 | 2% |
| Leica Biosystems Newcastle Ltd | 14 | 1% |
| Slmp, Llc | 7 | 0% |
| Biolegend, Inc. | 3 | 0% |
| Sakura Finetek U.S.A., Inc. | 2 | 0% |
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 | 1,363 |
| PPM | General Purpose Reagent | 72 |
| NTR | Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclo | 37 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 15 |
| LED | Stains, Chemical Solution | 3 |
| HYL | Hematoxylin Mayer'S | 2 |
Use these as the dimensions to specify in a tender line.
1,490 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry", from 10 companies. The largest labeler is Richard-Allan Scientific Company with 63% of records.
NJT (Immunohistochemistry Reagents And Kits), PPM (General Purpose Reagent), NTR (Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclo), 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.