A substance or reactant intended to be used together with a parent IVD to perform a specific function in an immunohistochemistry assay that is used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in
| Company | Devices | Share |
|---|---|---|
| Biocare Medical Llc | 41 | 45% |
| Biogenex Laboratories | 23 | 25% |
| Vitro Sa | 10 | 11% |
| Leica Biosystems Newcastle Ltd | 8 | 9% |
| Shenzhen Dakewe Bio-Engineering Co., Ltd | 6 | 7% |
| Diagnostic Biosystems, Inc. | 4 | 4% |
Company = labeler of record on GUDID. 6 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 |
|---|---|---|
| PPM | General Purpose Reagent | 46 |
| NJT | Immunohistochemistry Reagents And Kits | 28 |
| MVU | Reagents, Specific, Analyte | 18 |
Use these as the dimensions to specify in a tender line.
92 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Immunohistochemistry antibody detection IVD, reagent", from 6 companies. The largest labeler is Biocare Medical Llc with 45% of records.
PPM (General Purpose Reagent), NJT (Immunohistochemistry Reagents And Kits), MVU (Reagents, Specific, Analyte)
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.