Autoantibodies, Nuclear Body Protein, Sp100

NUM · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5090

Classification

FDA Product Code: NUM
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.5090
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 SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 5

Source

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