Product code NIY

Device name

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

Medical specialty

Immunology

Device class

2

Regulation number

866.5660

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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

Source

FDA openFDA device classification dataset