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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device autoantibodies, anti-soluble liver antigen (sla), autoimmune hepatitis
Regulation Description Multiple autoantibodies immunological test system.
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
Product CodeNIY
Regulation Number 866.5660
Device Class 2