[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: 21CFR862.1187]

[Page 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. 862.1187  Conjugated sulfolithocholic acid (SLCG) test system.

    (a) Identification. A conjugated sulfolithocholic acid (SLCG) test 
system is a device intended to measure the bile acid SLCG 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.