§ 862.1215. Creatine phosphokinase/creatine kinase or isoenzymes test system.
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/us/cfr/t21/s§ 862.1215·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
(b)Classification. Class II.