Product code OQZ
- Device name
- Anti-Mutated Citrullinated Vimentin Igg
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5775
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma.
- Source
- FDA openFDA device classification dataset