NPH — Antigen, Cartilage Oligomeric Matrix Protein (Comp) Class II
FDA product code NPH covers "Antigen, Cartilage Oligomeric Matrix Protein (Comp)", a Class II medical device regulated under 21 CFR 866.5775. Submissions are reviewed by the Immunology panel.
Classification Details
- Product Code
- NPH
- Device Class
- Class II
- Regulation Number
- 866.5775
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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.