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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device antibodies, anti-actin, anti-smooth muscle
Regulation Description Antismooth muscle antibody immunological test system.
Definition The device is used for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum as an aid in the diagnosis of certain autoimmune liver diseases, e.g. autoimmune hepatitis.
Product CodeNJF
Regulation Number 866.5120
Device Class 2