Title 21: Food and Drugs
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/ PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
/ Subpart I - Hematology Reagents / § 864.8100 Bothrops atrox reagent.
§ 864.8100 Bothrops atrox reagent.
(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).