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

FDA product code NYO · 4 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5100
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2006-06-19 – 2021-09-13

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.

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