21 CFR §866.3200

1. (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.
2. (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.