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    K Number
    K972796
    Device Name
    SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1997-10-10

    (74 days)

    Product Code
    GJS
    Regulation Number
    864.7750
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sigma Diagnostics ThromboMAX™ with Calcium is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

    Device Description

    Sigma ThromboMAX™ with Calcium is a lyophilized preparation of thromboplastin derived from rabbit brain with buffers, stabilizers, and calcium ions. It is intended for use in the one-stage Prothrombin Time (PT) test and in PT based assays.

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