[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: 21CFR866.3240]

[Page 247]
 
                        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. 866.3240  Equine encephalomyelitis virus serological reagents.

    (a) Identification. Equine encephalomyelitis virus serological 
reagents are devices that consist of antigens and antisera used in 
serological tests to identify antobodies to equine encephalomyelitis 
virus in serum. The identification aids in the diagnosis of diseases 
caused by equine encephalomyelitis viruses and provides epidemiological 
information on these viruses. Equine encephalomyelitis viruses are 
transmitted to humans by the bite of insects, such as mosquitos and 
ticks, and may cause encephalitis (inflammation of the brain), rash, 
acute arthritis, or hepatitis.
    (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]