---
kind: "section"
citation: "21 C.F.R. § 866.3870"
title: "21"
number: "866.3870"
heading: "Trypanosoma spp. serological reagents."
url: "https://uscodex.org/cfr/21/866.3870"
---

# §866.3870. Trypanosoma spp. serological reagents.

- (a) **Identification. Trypanosoma—** spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Trypanosoma spp. in serum. The identification aids in the diagnosis of trypanosomiasis, a disease caused by parasitic protozoans belonging to the genus Trypanosoma. Trypanosomiasis in adults is a chronic disease characterized by fever, chills, headache, and vomiting. Central nervous system involvement produces typical sleeping sickness syndrome: physical exhaustion, inability to eat, tissue wasting, and eventual death. Chagas disease, an acute form of trypanosomiasis in children, most seriously affects the central nervous system and heart muscle.
- (b) **Classification.** Class I (general controls).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.