Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

NIY · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5660

Classification

FDA Product Code: NIY
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.5660
Review panel: IM
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

ELISA for the detection of anti-SLA (soluble liver antigen) antibody of the IgG class. Intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis

Market data

Cleared 510(k) submissions: 3
Registered establishments: 5

Source

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