21 CFR 864.8100
§ 864.8100 Bothrops atrox reagent.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 864.8100, § 864.8100 Bothrops atrox reagent, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89395
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Full text
(a) Identification. A Bothrops atrox reagent is a device made from snake venom and used to determine blood fibrinogen levels to aid in the evaluation of disseminated intravascular coagulation (nonlocalized clotting in the blood vessels) in patients receiving heparin therapy (the administration of the anticoagulant heparin in the treatment of thrombosis) or as an aid in the classification of dysfibrinogenemia (presence in the plasma of functionally defective fibrinogen).
(b) Classification. Class II (performance standards).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.