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U.S. Department of Health and Human Services

Product Classification

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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.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNJF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5120
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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