K Number
K955115Device Name
VENOM TIEM REAGENTManufacturer
Date Cleared
1996-04-03
(146 days)
Product Code
Regulation Number
864.8100Type
TraditionalPanel
HEReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 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).