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Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
Immunology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

NYO

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Class 2

21 CFR 866.5100

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Immunology

Device Characteristics

No

No

No

Eligible

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.