510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OQZClass II

Anti-Mutated Citrullinated Vimentin Igg

21 CFR 866.5775 / Immunology
FDA source (opens on fda.gov)

OQZ is the FDA product code for Anti-Mutated Citrullinated Vimentin Igg, a class II device type, regulated under 21 CFR 866.5775. FDA's definition for this code reads: "For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OQZ
Device name
Anti-Mutated Citrullinated Vimentin Igg
FDA definition
For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma.
Regulation
21 CFR 866.5775
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code OQZ

By decision year
1 clearance under product code OQZ with a decision year between 2010 and 2010, 2010 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OQZ by decision year
YearClearances
20101

Applicants with the most clearances

Product code OQZ
Applicants holding the most 510(k) clearances under product code OQZ
ApplicantClearances
Orgentec Diagnostika GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code