[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.3145]

[Page 263]
 
                        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. 866.3145  Coxsackievirus serological reagents.

    (a) Identification. Coxsackievirus serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to coxsackievirus in serum. Additionally, some of 
these reagents consist of coxsackievirus antisera conjugated with a 
fluorescent dye that are used to identify coxsackievirus from clinical 
specimens or from tissue culture isolates derived from clinical 
specimens. The identification aids in the diagnosis of coxsackievirus 
infections and provides epidemiological information on diseases caused 
by these viruses. Coxsackieviruses produce a variety of infections, 
including common colds, meningitis (inflammation of brain and spinal 
cord membranes), herpangina (brief fever accompanied by ulcerated 
lesions of the throat), and myopericarditis (inflammation of heart 
tissue).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]