A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to smooth muscle in a clinical specimen, using a fluorescent immunoassay method.
| Company | Devices | Share |
|---|---|---|
| Scimedx Corporation | 66 | 99% |
| Zeus Scientific, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 2 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 |
|---|---|---|
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen | 50 |
| DBE | Antismooth Muscle Antibody, Indirect Immunofluorescent, Anti | 16 |
Use these as the dimensions to specify in a tender line.
67 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Smooth muscle antibody IVD, kit, fluorescent immunoassay", from 2 companies. The largest labeler is Scimedx Corporation with 99% of records.
DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen), DBE (Antismooth Muscle Antibody, Indirect Immunofluorescent, Anti)
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.