FDA product code OQZ: Anti-Mutated Citrullinated Vimentin Igg
OQZ is the FDA product code for anti-mutated citrullinated vimentin igg. It is a Class II device, regulated under 21 CFR 866.5775 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under OQZ. The average 510(k) review took 329 days (median 329).
Definition
For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma.
Classification
| Field | Value |
|---|---|
| Device name | Anti-Mutated Citrullinated Vimentin Igg |
| Device class | Class II |
| Regulation | 21 CFR 866.5775 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OQZ clearance
Top OQZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orgentec Diagnostika GmbH | 1 | 2010-07-01 |
Most recent OQZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092399 | Orgentec Diagnostika GmbH | ANTI-MUTATED CITRULLINATED VIMENTIN EIA | 2010-07-01 | 329 |
Recalls for OQZ devices
openFDA lists no recalls for product code OQZ.
Frequently asked questions
What is FDA product code OQZ?
OQZ is the FDA product code for anti-mutated citrullinated vimentin igg. It is a Class II device, regulated under 21 CFR 866.5775 and reviewed by the Immunology panel.
What device class is OQZ?
Class II, regulation 21 CFR 866.5775. Typical premarket route: 510(k).
How long does a 510(k) take for product code OQZ?
Across 1 cleared submissions the average was 329 days from receipt to decision (median 329).
Which companies have the most OQZ clearances?
Orgentec Diagnostika GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OQZ
- Run a recall and safety report across every OQZ manufacturer
- Watch product code OQZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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