OQZ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Anti-Mutated Citrullinated Vimentin Igg
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5775
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA definition
- For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma.
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| Record | Firm | Date |
|---|---|---|
| ANTI-MUTATED CITRULLINATED VIMENTIN EIA (K092399) | Orgentec Diagnostika GmbH | 2010-07-01 |
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