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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antigen, cartilage oligomeric matrix protein (comp)
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.
Product CodeNPH
Regulation Number 866.5775
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body Reaction 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Necrosis 1 1
Pain 1 1
Osteolysis 1 1
Ambulation Difficulties 1 1

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