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U.S. Department of Health and Human Services

Product Classification

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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
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNIY
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5660
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons