Product code NPH
- Device name
- Antigen, Cartilage Oligomeric Matrix Protein (Comp)
- 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
- COMP ELISA is a quantitative enzyme-linked immunosorbent assay for detecting COMP (Cartilage Oligomeric Matrix Protein) in patient sera. The presence of elevated levels, when considered in conjunction with other laboratory and clinical findings, aids in identifying aggressive destruction of joint tissue in Rheumatoid Arthritis.
- Source
- FDA openFDA device classification dataset