(a)Identification. Trichinella spiralis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toTrichinella spiralis in serum. The identification aids in the diagnosis of trichinosis caused by parasitic roundworms belonging to the genusTrichinella and provides epidemiological information on trichinosis. Trichinosis is caused by ingestion of undercooked, infested meat, especially pork, and characterized by fever, muscle weakness, and diarrhea.
(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 2312, Jan. 14, 2000]