A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple anti-neutrophil cytoplasmic antibodies (ANCA) in a clinical specimen, using a fluorescent immunoassay method.
| Company | Devices | Share |
|---|---|---|
| Euroimmun Medizinische Labordiagnostika Ag | 43 | 46% |
| Immuno Concepts Inc | 18 | 19% |
| Immco Diagnostics, Inc. | 12 | 13% |
| Inova Diagnostics, Inc. | 8 | 9% |
| Scimedx Corporation | 5 | 5% |
| Zeus Scientific, Inc. | 4 | 4% |
| Aesku.Diagnostics Gmbh & Co. Kg | 3 | 3% |
| Bio-Rad Laboratories, Inc. | 1 | 1% |
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 |
|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 111 |
| PIV | Automated Indirect Immunofluorescence Microscope And Softwar | 34 |
| MOB | TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA) | 1 |
Use these as the dimensions to specify in a tender line.
94 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay", from 8 companies. The largest labeler is Euroimmun Medizinische Labordiagnostika Ag with 46% of records.
MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), PIV (Automated Indirect Immunofluorescence Microscope And Softwar), MOB (TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA))
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.