One or multiple immunoglobulins with the capability of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of antigens from Helicobacter pylori bacteria in a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Diagnostic Biosystems, Inc. | 24 | 38% |
| Biocare Medical Llc | 17 | 27% |
| Slmp, Llc | 10 | 16% |
| Fuzhou Maixin Biotech Co., Ltd. | 4 | 6% |
| Agilent Technologies Singapore Pte Ltd | 2 | 3% |
| Leica Biosystems Newcastle Ltd | 2 | 3% |
| Ventana Medical Systems, Inc. | 2 | 3% |
| Sakura Finetek U.S.A., Inc. | 2 | 3% |
Company = labeler of record on GUDID. 8 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 | 39 |
| MVU | Reagents, Specific, Analyte | 19 |
| MVU | Reagents, specific, analyte | 2 |
| OWF | Immunohistochemical assay, Helicobacter pylori | 2 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 2 |
Use these as the dimensions to specify in a tender line.
63 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Helicobacter pylori antigen IVD, antibody", from 8 companies. The largest labeler is Diagnostic Biosystems, Inc. with 38% of records.
NJT (Immunohistochemistry Reagents And Kits), MVU (Reagents, Specific, Analyte), MVU (Reagents, specific, analyte), OWF (Immunohistochemical assay, Helicobacter pylori)
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.