Product Classification

• 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 Code: NYO
• Premarket Review: Division of Immunology and Hematology Devices (DIHD); 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 Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc