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510(k) Data Aggregation

    K Number
    K251968
    Device Name
    HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
    Manufacturer
    Instrumentation Laboratory (IL) Co.
    Date Cleared
    2025-07-24

    (28 days)

    Product Code
    KQJ
    Regulation Number
    864.7340
    Why did this record match?
    Product Code :

    KQJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K073367
    Device Name
    HEMOSIL FIBRINOGEN-C
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2007-12-27

    (27 days)

    Product Code
    KQJ
    Regulation Number
    864.7340
    Why did this record match?
    Product Code :

    KQJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemosIL Fibrinogen-C is intended for the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems. For in vitro diagnostic use.
    Device Description
    The Fibrinogen-C kit uses an excess of thrombin to convert fibrinogen to fibrin in diluted plasma. At high thrombin and low fibrinogen concentration, the rate of reaction is a function of the fibrinogen concentration.
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    K Number
    K050928
    Device Name
    DADE THROMBIN REAGENT
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2005-06-29

    (76 days)

    Product Code
    KQJ
    Regulation Number
    864.7340
    Why did this record match?
    Product Code :

    KQJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies.
    Device Description
    Fibrinogen is a plasma protein which is converted from a soluble protein to an insoluble polymer by the action of thrombin resulting in the formation of a fibrin clot. The thrombin clotting time of dilute plasma is inversely proportional to the fibrinogen concentration of the plasma. Using this principle, Clauss developed a simple quantitative assay for fibrinogen by measuring the clotting time of dilute plasma when excess thrombin is added. The clotting time obtained is then compared with that of a standardized fibrinogen preparation.
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    K Number
    K971858
    Device Name
    SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1997-10-09

    (142 days)

    Product Code
    KQJ
    Regulation Number
    864.7340
    Why did this record match?
    Product Code :

    KQJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sigma Diagnostics Fibrinogen Kit is a device used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).
    Device Description
    The method of Clauss measures the rate of fibrin conversion in the presence of excess thrombin and has been shown to be rapid, sensitive and precise. When diluted plasma is clotted with excess thrombin, the fibrinogen level is inversely proportional to the clotting time, vielding a curvilinear relationship when plotted on loglog paper. A calibration curve prepared from a fibrinogen reference is used to determine the fibrinogen concentration in the test sample.
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    K Number
    K970189
    Device Name
    FIF TM
    Manufacturer
    PANBIO, INC.
    Date Cleared
    1997-05-21

    (120 days)

    Product Code
    KQJ, GIS
    Regulation Number
    864.7340
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    Product Code :

    KQJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A fibrinogen determination test is indicated for testing of conditions in which blood coagulation is involved. Such conditions include disseminated intravascular coaagulation, cardiovascular disease and primary fibrinolysis.
    Device Description
    The ABS, Inc. FiF™ Test is an immunoprecipitation test indicated for the quantitative determination of fibrinogen in human plasma. The FiR™ test employs a monoclonal antibody (Mab), specific for intact (undegraded) plasma fibrinogen. When added to a plasma sample the FiFTM MAb precipitates the fibrinogen from solution. The extent of the immunoprecipitate is determined by measuring the change in sample absorbance (at 340nm) after the addition of the FiFTM antibody. There is a linear correlation between the change in sample O.D. at 340nm and the concentration of fibrinogen in the solution. The test is calibrated using a standardized plasma sample provided with the kit.
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    K Number
    K965113
    Device Name
    N-ASSAY TIA FIBRINOGEN TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-04-16

    (117 days)

    Product Code
    KQJ, DAZ, GIS
    Regulation Number
    864.7340
    Why did this record match?
    Product Code :

    KQJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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