[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1177]

[Page 181-182]
 
                        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

[[Page 182]]

are used in the diagnosis and treatment of liver disorders, such as 
cirrhosis or obstructive liver disease.
    (b) Classification. Class II.