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510(k) Data Aggregation

    K Number
    K132076
    Device Name
    REAGENT, RUSSEL VIPER VENOM - LA CONFIRM
    Manufacturer
    DSRV, INC.
    Date Cleared
    2014-01-10

    (191 days)

    Product Code
    GIR
    Regulation Number
    864.8950
    Why did this record match?
    Applicant Name (Manufacturer) :

    DSRV, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests. Frozen Format LA Confirm is a phospholipid-rich DRVVT reagent for the specific correction of Lupus Anticoagulants. This product is for in-vitro diagnostic use only.
    Device Description
    Frozen Format LA Confirm is a phospholipid-rich DRVVT reagent for the specific correction of Lupus Anticoagulants.
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    K Number
    K132130
    Device Name
    REAGENT, RUSSEL VIPER VENOM - LA SCREEN
    Manufacturer
    DSRV, INC.
    Date Cleared
    2014-01-10

    (184 days)

    Product Code
    GIR
    Regulation Number
    864.8950
    Why did this record match?
    Applicant Name (Manufacturer) :

    DSRV, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests. Frozen Format LA Screen is a simplified DRVVT reagent to screen for the presence of Lupus Anticoagulants. This product is for in-vitro diagnostic use only.
    Device Description
    Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests.
    Ask a Question

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