NYO

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

Product code

NYO

Device name

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

Device class

Class 2

21 CFR

21 CFR 866.5100

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).