PET

Anti-Ss-A Ro60 Autoantibodies

Product code

PET

Device name

Anti-Ss-A Ro60 Autoantibodies

Device class

Class 2

21 CFR

21 CFR 866.5100

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification definition

Ro60 assays are designed for the determination of IgG anti-Ro60 (SS-A Ro60) autoantibodies in human serum. The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus and Sjögren's Syndrome.

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