[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1215]

[Page 184]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES--Table of Contents
 
               Subpart B--Clinical Chemistry Test Systems
 
Sec. 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.