21 CFR 864.8100 — Bothrops Atrox Reagent

Hematology (HE) · Part 864 Subpart I—Hematology Reagents · § 864.8100

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).

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
JCOBothrops Atrox Reagent273rd Party
Innolitics

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