Data / Medical devices / Autoantibodies, Endomysial(Tissue Transglutaminase)

Autoantibodies, Endomysial(Tissue Transglutaminase) (MVM): 14 FDA-registered makers in 4 countries

Name: FDA-registered makers of Autoantibodies, Endomysial(Tissue Transglutaminase)
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

14 establishments in 4 countries are registered with the FDA to make Autoantibodies, Endomysial(Tissue Transglutaminase) (product code MVM, Class 2, 21 CFR 866.5660). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 40 510(k) clearances under this code, the latest on August 26, 2021, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code: MVM
Device class: 2
Regulation: 866.5660
Medical specialty: Immunology

Makers by country

Country	Makers
United States	8
Germany	4
Sweden	1
Italy	1

Makers of Autoantibodies, Endomysial(Tissue Transglutaminase)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Source
Inova Diagnostics, Inc.	San Diego, CA, United States	Manufacturer, Manufacturer for export	11	August 26, 2021	api.fda.gov
Phadia AB	Uppsala, Sweden	Complaint file establishment, Manufacturer	3	March 1, 2019	api.fda.gov
Euroimmun Medizinische Labordiagnostika AG	Luebeck Schleswig-Holstein, Germany	Manufacturer	2	February 28, 2019	api.fda.gov
EUROIMMUN Medizinische Labordiagnostika AG	Dassow Mecklenburg-Western Pomerania, Germany	Manufacturer	2	February 28, 2019	api.fda.gov
Immco Diagnostics, Inc.	Williamsville, NY, United States	Manufacturer	2	March 10, 2010	api.fda.gov
AESKU.DIAGNOSTICS GmbH&Co.KG	WENDELSHEIM Rhineland-Palatinate, Germany	Manufacturer	1	June 1, 2005	api.fda.gov
Bio-Rad Laboratories, Inc.	Hercules, CA, United States	Complaint file establishment, Specification developer	1	September 19, 2013	api.fda.gov
Eurospital S.P.A.	Trieste, Italy	Manufacturer	1	March 7, 2011	api.fda.gov
Theratest Laboratories, Inc.	Lombard, IL, United States	Manufacturer	1	November 5, 2007	api.fda.gov
Zeus Scientific LLC	Branchburg, NJ, United States	Manufacturer, Repackager or relabeler	1	November 1, 1999	api.fda.gov
Bio-Rad Laboratories, Inc.	Woodinville, WA, United States	Contract manufacturer	0		api.fda.gov
Epitope Diagnostics, Inc.	San Diego, CA, United States	Manufacturer for export	0		api.fda.gov
Immunocentrix Corporation	Canoga Park, CA, United States	Manufacturer for export	0		api.fda.gov
Phadia GMBH	FREIBURG Baden-Wurttemberg, Germany	Contract manufacturer	0		api.fda.gov

Updated August 26, 2021. 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.