Data / Medical devices / Autoantibodies, Endomysial(Tissue Transglutaminase) / United States
FDA-registered makers of Autoantibodies, Endomysial(Tissue Transglutaminase) in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Autoantibodies, Endomysial(Tissue Transglutaminase) (product code MVM). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Autoantibodies, Endomysial(Tissue Transglutaminase)
- Product code
- MVM
- Country
- United States
Makers of Autoantibodies, Endomysial(Tissue Transglutaminase) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 11 | August 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Immco Diagnostics, Inc. | Williamsville, NY, United States | Manufacturer | 2 | March 10, 2010 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 1 | September 19, 2013 | 0 | 0 | 0 | api.fda.gov |
| Theratest Laboratories, Inc. | Lombard, IL, United States | Manufacturer | 1 | November 5, 2007 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer, Repackager or relabeler | 1 | November 1, 1999 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.