FDA product code NPH

Antigen, Cartilage Oligomeric Matrix Protein (Comp)

Immunology·Class 2·21 CFR 866.5775
US regulatory classifications
US Product Code (FDA)
NPH
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.5775
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Medical specialty
Immunology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
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.

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About this record

Antigen, Cartilage Oligomeric Matrix Protein (Comp) is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.