VENOM TIEM REAGENT

• K Number: K955115
• Device Name: VENOM TIEM REAGENT
• Manufacturer: MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
• Date Cleared: 1996-04-03 ( 146 days)
• Product Code: JCO
• Regulation Number: 864.8100

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 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).

Summary

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