[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: 21CFR862.1110]

[Page 179]
 
                        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. 862.1110  Bilirubin (total or direct) test system.

    (a) Identification. A bilirubin (total or direct) test system is a 
device intended to measure the levels of bilirubin (total or direct) in 
plasma or serum. Measurements of the levels of bilirubin, an organic 
compound formed during the normal and abnormal distruction of red blood 
cells, if used in the diagnosis and treatment of liver, hemolytic 
hematological, and metabolic disorders, including hepatitis and gall 
bladder block.
    (b) Classification. Class II.