21 CFR 866.3850
§ 866.3850
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.3850, § 866.3850, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89568
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Full text
(a) Identification. Trichinella spiralis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Trichinella spiralis in serum. The identification aids in the diagnosis of trichinosis caused by parasitic roundworms belonging to the genus Trichinella 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.