[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: 21CFR866.3205]

[Page 246]
 
                        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. 866.3205  Echovirus serological reagents.

    (a) Identification. Echovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to echovirus in serum. Additionally, some of these reagents 
consist of echovirus antisera conjugated with a fluorescent dye used to 
identify echoviruses from clinical specimens or from tissue culture 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of echovirus infections and provides epidemiological 
information on diseases caused by these viruses. Echoviruses cause 
illnesses such as meningitis (inflammation of the brain and spinal cord 
membranes), febrile illnesses (accompanied by fever) with or without 
rash, and the common cold.
    (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 the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]