Antigen, Cartilage Oligomeric Matrix Protein (Comp)
NPH is the FDA product code for Antigen, Cartilage Oligomeric Matrix Protein (Comp), a class II device type, regulated under 21 CFR 866.5775. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- NPH
- Device name
- Antigen, Cartilage Oligomeric Matrix Protein (Comp)
- FDA 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.
- Regulation
- 21 CFR 866.5775
- Device class
- Class II
- Review panel
- Immunology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code NPH.
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