§ 866.5090. Antimitochondrial antibody immunological test system.
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/us/cfr/t21/s§ 866.5090·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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).