[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: 21CFR866.3235]

[Page 244]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES--Table of Contents
 
                     Subpart D--Serological Reagents
 
Sec. 866.3235  Epstein-Barr virus serological reagents.

    (a) Identification. Epstein-Barr virus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Epstein-Barr virus in serum. The 
identification aids in the diagnosis of Epstein-Barr virus infections 
and provides epidemiological information on diseases caused by these 
viruses. Epstein-Barr viruses are thought to cause infectious 
mononucleosis and have been associated with Burkitt's lymphoma (a tumor 
of the jaw in African children and young adults) and postnasal carcinoma 
(cancer).
    (b) Classification. Class I (general controls).