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47 FR 50823, Nov. 9, 1982, unless otherwise noted.
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Subscribe to: 21 CFR 866.5120
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Nomenclature changes to part 866 appear at 73 FR 35341, June 23, 2008.
(a) Identification. An antismooth muscle antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antismooth muscle antibodies (antibodies to nonstriated, involuntary muscle) in serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune connective tissue diseases (diseases resulting from antibodies produced against the body's own tissues).
(b) Classification Class II (performance standards).