DeviceClearance

Product code OQZ— Immunology

ANTI-MUTATED CITRULLINATED VIMENTIN EIA

Classification name
Anti-Mutated Citrullinated Vimentin Igg
Device class
Class 2
Regulation
21 CFR 866.5775
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code OQZ under 21 CFR 866.5775, via openFDA

Market context for product code OQZ

FDA has cleared 1 device under product code OQZ, all in 2010, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OQZ

Recent clearances under product code OQZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.