(a)Identification. Echinococcus spp. serological reagents are devices that consist ofEchinococcus spp. antigens and antisera used in serological tests to identify antibodies toEchinococcus spp. in serum. The identification aids in the diagnosis of echinococcosis, caused by parasitic tapeworms belonging to the genusEchinococcus 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 866.9.
[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]