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U.S. Department of Health and Human Services

Product Classification

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Device autoantibodies, anti-ribonucleic acid polymerase (rnap) iii antibody
Regulation Description Antinuclear antibody immunological test system.
Definition The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use.
Physical State Antibody ELISA kit, Antigen and Controls
Technical Method The ELISA test result aids in the diagnosis of Systemic Sclerosis (SSc)
Target Area Blood Serum
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNYO
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5100
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