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PETClass II

Anti-Ss-A Ro60 Autoantibodies

21 CFR 866.5100 / Immunology
FDA source (opens on fda.gov)

PET is the FDA product code for Anti-Ss-A Ro60 Autoantibodies, a class II device type, regulated under 21 CFR 866.5100. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PET
Device name
Anti-Ss-A Ro60 Autoantibodies
FDA 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.
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code