NIY

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

Product code: NIY
Device name: Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
Device class: Class 2
21 CFR: 21 CFR 866.5660
Medical specialty: Immunology
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (all years, FDA): 3 (all years; only the last 3 years are listed here)

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: NIY

Classification and pathway per current FDA publications. Data from openFDA (CC0).