FDA product code OQZ

Anti-Mutated Citrullinated Vimentin Igg

Immunology·Class 2·21 CFR 866.5775
US regulatory classifications
US Product Code (FDA)
OQZ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.5775
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Medical specialty
Immunology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma.

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About this record

Anti-Mutated Citrullinated Vimentin Igg is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.