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

FDA product code NIY · 3 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5660
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2002-07-30 – 2013-04-12

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

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