21 CFR 862.1215
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 862.1215, § 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89083
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.