Antigen, Cartilage Oligomeric Matrix Protein (Comp)

NPH · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5775

Classification

FDA Product Code: NPH
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.5775
Review panel: IM
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown