[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: 21CFR866.3175]

[Page 243]
 
                        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. 866.3175  Cytomegalovirus serological reagents.

    (a) Identification. Cytomegalovirus serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to cytomegalovirus in serum. The identification aids 
in the diagnosis of diseases caused by cytomegaloviruses (principally 
cytomegalic inclusion disease) and provides epidemiological information 
on these diseases. Cytomegalic inclusion disease is a generalized 
infection of infants and is caused by intrauterine or early postnatal 
infection with the virus. The disease may cause severe congenital 
abnormalities, such as microcephaly (abnormal smallness of the head), 
motor disability, and mental retardation. Cytomegalovirus infection has 
also been associated with acquired hemolytic anemia, acute and chronic 
hepatitis, and an infectious mononucleosis-like syndrome.
    (b) Classification. Class II (performance standards).