BEUDAMED
    Product Code: QFR FDA class 2 21 CFR 864.5430

    Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties

    Hematology

    The Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both in patients by measuring the viscoelastic properties of whole blood, providing comprehensive information on clot formation and breakdown dynamics. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 864.5430 in the Hematology specialty. The product code is QFR. It is not an implant and is not life-sustaining.

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    510(k)s
    8
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    6

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    Basic Information

    Product Code
    QFR
    Device Class
    FDA class 2
    Regulation Number
    864.5430
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A coagulation system for the measurement of whole blood viscoelastic properties is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in patients.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 8 510(k) clearances via K numbers.

    K Number Device Name
    K251404 Quantra QStat Cartridge
    K240045 QStat Cartridge
    K232215 Quantra Hemostasis Analyzer
    K230461 Quantra Hemostasis Analyzer
    K223433 Quantra QPlus System
    K213917 QStat Cartridge
    K201513 Quantra QPlus System
    DEN180017 Quantra Hemostasis Analyzer, QPlus Cartridge

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.