NPH

Antigen, Cartilage Oligomeric Matrix Protein (Comp)

Product code

NPH

Device name

Antigen, Cartilage Oligomeric Matrix Protein (Comp)

Device class

Class 2

21 CFR

21 CFR 866.5775

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).