21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system

Subpart B - Clinical Chemistry Test Systems Official text on eCFR Amendment history

(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.

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Amendment history

Federal Register documents that created or amended this section.