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ANTI-MCV

ORGENTEC Diagnostika GmbH · Model ORG548 · UDI-DI 04260157080539

OQZ Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
1
Facilities

Description

Anti-MCV® is an ELISA test system for the qualitative and semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma. This product is intended for professional in vitro diagnostic use as an aid in the diagnosis of Rheumatoid Arthritis in conjuction with other laboratory and clinical findings.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.