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U.S. Department of Health and Human Services

Product Classification

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Device antibodies, anti-cyclic citrullinated peptide (ccp)
Regulation Description Rheumatoid factor immunological test system.
Definition The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNHX
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons