K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT

• K Number: K002948
• Device Name: K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
• Manufacturer: KAMIYA BIOMEDICAL CO.
• Date Cleared: 2001-05-18 ( 239 days)
• Product Code: DAP
• Regulation Number: 864.7320

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

§ 864.7320 Fibrinogen/fibrin degradation products assay.

(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).

Summary

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