Product Classification

• 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 Code: OQZ
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.5775
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc