BEUDAMED
    4 results · 54ms · Sources: EU EUDAMED, US FDA

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    CLEARVIEW SIMPLIFY D-DIMER

    FDA Adverse Event
    BBI SOLUTIONS OEM LTD·Product code GHH·December 2, 2015

    SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood

    FDA Enforcement
    Class II ·Terminated·BBI SOLUTIONS OEM LTD·November 2, 2016

    SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood

    FDA Recall
    Terminated ·BBI SOLUTIONS OEM LTD 8 Tom McDonald Avenue Dundee United Kingdom·Product code GHH·June 1, 2016

    SUNGO Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1571 Manufacturers·20390 Devices