21 C.F.R. § 862.1215

Creatine phosphokinase/creatine kinase or isoenzymes test system.

Last amended: 2016Year: 2026Length: 68 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 862.1215 (2026)

(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.
21 C.F.R. § 862.1215: Creatine phosphokinase/creatine kinase or isoenzymes test system. | Justis AI