FDA Product Code NYO: Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody
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.
Leading manufacturers include Phadia AB.
List of Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody devices (product code NYO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Immunology FDA review panel. Browse all Immunology devices →