Anti-Ss-A Ro60 Autoantibodies

PET · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5100

Classification

FDA Product Code: PET
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.5100
Review panel: IM
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown