[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1113]

[Page 187]
 
                        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 infants to aid in 
indicating the risk of bilirubin encephalopathy (kernicterus).
    (b) Classification. Class I.

[54 FR 30206, July 19, 1989]