Product code OKM
- Device name
- Antibodies, Outer-Membrane Proteins
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5785
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum. To aid in the diagnosis of Crohn's Disease.
- Source
- FDA openFDA device classification dataset