Anti-Ss-A 52 Autoantibodies

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

Classification

FDA Product Code: OBE
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

The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 1

Source

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