[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1050]

[Page 186]
 
                        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. 862.1050  Alkaline phosphatase or isoenzymes test system.

    (a) Identification. An alkaline phosphatase or isoenzymes test 
system is a device intended to measure alkaline phosphatase or its 
isoenzymes (a group of enzymes with similar biological activity) in 
serum or plasma. Measurements of alkaline phosphatase or its isoenzymes 
are used in the diagnosis and treatment of liver, bone, parathyroid, and 
intestinal diseases.
    (b) Classification. Class II.