Multiple immunoglobulins (antibody cocktail) capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple proteins/markers associated with more than one specific tissue or solid tum
| Company | Devices | Share |
|---|---|---|
| Biocare Medical Llc | 47 | 64% |
| Biogenex Laboratories | 24 | 33% |
| Diagnostic Biosystems, Inc. | 2 | 3% |
Company = labeler of record on GUDID. 3 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 | 72 |
| FDA | Enteroscope And Accessories | 1 |
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73 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple solid tumour differentiation marker IVD, antibody", from 3 companies. The largest labeler is Biocare Medical Llc with 64% of records.
NJT (Immunohistochemistry Reagents And Kits), FDA (Enteroscope And Accessories)
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.