21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1215

Creatine phosphokinase/creatine kinase or isoenzymes test system.

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21 C.F.R. § 862.1215 — Creatine phosphokinase/creatine kinase or isoenzymes test system.

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system. (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.

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 862.1215
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The regulatory text of 21 C.F.R. § 862.1215 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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boisestandard.org United States Law CFR Title 21 21 C.F.R. § 862.1215