[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: 21CFR862.1113]

[Page 180-181]
 
                        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. 862.1113  Bilirubin (total and unbound) in the neonate test system.

    (a) Identification. A bilirubin (total and unbound) in the neonate 
test system is a device intended to measure the levels of bilirubin 
(total and unbound) in the blood (serum) of newborn

[[Page 181]]

infants to aid in indicating the risk of bilirubin encephalopathy 
(kernicterus).
    (b) Classification. Class I.

[54 FR 30206, July 19, 1989]