OQZ

Anti-Mutated Citrullinated Vimentin Igg

Product code

OQZ

Device name

Anti-Mutated Citrullinated Vimentin Igg

Device class

Class 2

21 CFR

21 CFR 866.5775

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).