[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.7100]

[Page 246]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 864_HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents
 
                 Subpart H_Hematology Kits and Packages
 
Sec. 864.7100  Red blood cell enzyme assay.

    (a) Identification. Red blood cell enzyme assay is a device used to 
measure the activity in red blood cells of clinically important 
enzymatic reactions and their products, such as pyruvate kinase or 2,3-
diphosphoglycerate. A red blood cell enzyme assay is used to determine 
the enzyme defects responsible for a patient's hereditary hemolytic 
anemia.
    (b) Classification. Class II (performance standards).

[45 FR 60610, Sept. 12, 1980]