A collection of reagents and other associated materials intended to be used for the discrete visualisation of immune complexes bound to specific cellular markers in a clinical specimen. Sustrates are used to detect immunoperoxidase-bound complexes and may incl
| Company | Devices | Share |
|---|---|---|
| Bio Sb, Inc. | 70 | 45% |
| Biocare Medical Llc | 28 | 18% |
| Diagnostic Biosystems, Inc. | 21 | 13% |
| Sakura Finetek U.S.A., Inc. | 10 | 6% |
| Biogenex Laboratories | 7 | 4% |
| Ventana Medical Systems, Inc. | 5 | 3% |
| Lumatas Biosystems, Inc. | 5 | 3% |
| Novodiax, Inc. | 5 | 3% |
| Slmp, Llc | 4 | 3% |
| Immco Diagnostics, 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 | 108 |
| PPM | General Purpose Reagent | 20 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 17 |
| PPM | General purpose reagent | 9 |
| KPA | SLIDE STAINER, AUTOMATED | 1 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 1 |
Use these as the dimensions to specify in a tender line.
156 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry", from 10 companies. The largest labeler is Bio Sb, Inc. with 45% of records.
NJT (Immunohistochemistry Reagents And Kits), PPM (General Purpose Reagent), NJT (IMMUNOHISTOCHEMISTRY REAGENTS AND KITS), PPM (General purpose reagent)
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.