(a) Identification. Schistosoma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Schistosoma spp. in serum. The identification aids in the diagnosis of schistosomiasis caused by parasitic flatworms of the genus Schistosoma. Schistosomiasis is characterized by a variety of acute and chronic infections. Acute infection is marked by fever, allergic symptoms, and diarrhea. Chronic effects are usually severe and are caused by fibrous degeneration of tissue around deposited eggs of the parasite in the liver, lungs, and central nervous system. Schistosomes can also cause schistosome dermatitis (e.g., swimmer's itch), a skin disease marked by intense itching.
(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.