FDA product code NYO

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

Immunology·Class 2·21 CFR 866.5100
US regulatory classifications
US Product Code (FDA)
NYO
View Product Code Classification →
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.5100
View CFR Regulation →
Medical specialty
Immunology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
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.

Search keywords
About this record

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.