BEUDAMED
    21 results · 34ms · Sources: EU EUDAMED, US FDA

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    ENABLE BIOSCIENCES

    FDA registration
    ENABLE BIOSCIENCES·1 product·🇺🇸 United States

    Enable Blood Spot Collection Kit

    FDA UDI
    Enable Biosciences Inc.·00860010987803·Sample Collection Kit Dried Blood Spot and Kit ...

    G8

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·March 8, 2018

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·March 19, 2018

    AIA-900

    FDA Adverse Event
    Malfunction ·TOSOH HI-TEC·Product code KHO·September 14, 2017

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·March 21, 2018

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·March 15, 2018

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·March 14, 2018

    AIA-600II

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code KHO·April 13, 2018

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·March 22, 2018

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·March 14, 2018

    AIA-2000

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code KHO·February 15, 2018

    AIA-900

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code KHO·November 17, 2017

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 21, 2017

    AIA-900

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code KHO·January 28, 2019

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·September 18, 2018

    AIA-360

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code KHO·February 26, 2018

    AIA-360

    FDA Adverse Event
    Malfunction ·TOSOH BIOSCIENCE, INC.·Product code KHO·June 14, 2018

    AIA-360

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code KHO·June 29, 2018

    G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code LCP·June 6, 2018