Antibodies, Anti-Actin, Anti-Smooth Muscle

NJF · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5120

Classification

FDA Product Code: NJF
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.5120
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 semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum as an aid in the diagnosis of certain autoimmune liver diseases, e.g. autoimmune hepatitis.

Market data

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

Source

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