Title 21: Food and Drugs
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/ PART 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES
/ Subpart F - Immunological Test Systems / § 866.5090 Antimitochondrial antibody immunological test system.
§ 866.5090 Antimitochondrial antibody immunological test system.
(a) Identification. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).
(b) Classification. Class II (performance standards).