One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of gross cystic disease fluid protein-15 (GCDFP-15), also known as BRST-2 antigen or prolactin-induc
| Company | Devices | Share |
|---|---|---|
| Cell Marque Corporation | 14 | 23% |
| Bio Sb, Inc. | 14 | 23% |
| Diagnostic Biosystems, Inc. | 7 | 12% |
| Biocare Medical Llc | 5 | 8% |
| Epitomics Inc. | 5 | 8% |
| Fuzhou Maixin Biotech Co., Ltd. | 4 | 7% |
| Leica Biosystems Newcastle Ltd | 4 | 7% |
| Biogenex Laboratories | 3 | 5% |
| Sakura Finetek U.S.A., Inc. | 2 | 3% |
| Agilent Technologies, Inc. | 1 | 2% |
| Slmp, Llc | 1 | 2% |
Company = labeler of record on GUDID. 11 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 | 55 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 6 |
| LJG | QUALITY CONTROL SLIDES | 1 |
| LJG | Quality Control Slides | 1 |
Use these as the dimensions to specify in a tender line.
60 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gross cystic disease fluid protein-15 IVD, antibody", from 11 companies. The largest labeler is Cell Marque Corporation with 23% of records.
NJT (Immunohistochemistry Reagents And Kits), NJT (IMMUNOHISTOCHEMISTRY REAGENTS AND KITS), LJG (QUALITY CONTROL SLIDES), LJG (Quality Control Slides)
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.