[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: 21CFR866.3200]

[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. 866.3200  Echinococcus spp. serological reagents.

    (a) Identification. Echinococcus spp. serological reagents are 
devices that consist of Echinococcus spp. antigens and antisera used in 
serological tests to identify antibodies to Echinococcus spp. in serum. 
The identification aids in the diagnosis of echinococcosis, caused by 
parasitic tapeworms belonging to the genus Echinococcus and provides 
epidemiological information on this disease. Echinococcosis is 
characterized by the development of cysts in the liver, lung, kidneys, 
and other organs formed by the larva of the infecting organisms.
    (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]