OQZ — Anti-Mutated Citrullinated Vimentin Igg Class II

FDA Device Classification

Classification Details

Product Code
OQZ
Device Class
Class II
Regulation Number
866.5775
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K092399orgentec diagnostikaANTI-MUTATED CITRULLINATED VIMENTIN EIAJuly 1, 2010