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U.S. Department of Health and Human Services

Product Classification

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Device antigen, cartilage oligomeric matrix protein (comp)
Regulation Description Rheumatoid factor immunological test system.
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 Medical Specialty Immunology
Review Panel Immunology
Product CodeNPH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5775
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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