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U.S. Department of Health and Human Services

Product Classification

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Device anti-mutated citrullinated vimentin igg
Regulation Description Rheumatoid factor immunological test system.
Definition For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma.
Physical State antigen coated microtiter wells, calibrators, controls, enzyme conjugate and substrate, buffer
Technical Method Enzyme Immunoassay (ELISA)
Target Area Serum or plasma
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOQZ
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible