A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-endomysial antibodies (anti-EMA) in a clinical specimen, using a fluorescent immunoassay method.
| Company | Devices | Share |
|---|---|---|
| Immco Diagnostics, Inc. | 14 | 25% |
| Scimedx Corporation | 14 | 25% |
| Euroimmun Medizinische Labordiagnostika Ag | 13 | 24% |
| Immuno Concepts Inc | 12 | 22% |
| Zeus Scientific, Inc. | 1 | 2% |
| Inova Diagnostics, Inc. | 1 | 2% |
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 |
|---|---|---|
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 37 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen | 9 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay", from 6 companies. The largest labeler is Immco Diagnostics, Inc. with 25% of records.
MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)), DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen)
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.