[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: 21CFR862.1177]

[Page 183]
 
                        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. 862.1177  Cholylglycine test system.

    (a) Identification. A cholylglycine test system is a device intended 
to measure the bile acid cholylglycine in serum. Measurements obtained 
by this device are used in the diagnosis and treatment of liver 
disorders, such as cirrhosis or obstructive liver disease.
    (b) Classification. Class II.