BEUDAMED
    9 results · 70ms · Sources: EU EUDAMED, US FDA

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    Bordetella Direct Test

    FDA UDI
    GREAT BASIN SCIENTIFIC, INC.·B178GBBORD100·Bordetella Direct Test Cartridge

    Stool Bacterial Pathogens Panel

    FDA UDI
    GREAT BASIN SCIENTIFIC, INC.·B178GBSBPP100·Stool Bacterial Pathogens Panel Cartridge with ...

    Group B Strep Assay

    FDA UDI
    GREAT BASIN SCIENTIFIC, INC.·B178GBGBS100·

    Shiga Toxin Direct Test

    FDA UDI
    GREAT BASIN SCIENTIFIC, INC.·B178GBSTEC100·Shiga Toxin Direct Test Cartridge with sample p...

    Staph ID/R Blood Culture Panel

    FDA UDI
    GREAT BASIN SCIENTIFIC, INC.·B178GBSIDR100·

    PA500 Portrait Analyzer

    FDA UDI
    GREAT BASIN SCIENTIFIC, INC.·B178PA5000·

    Portrait Toxigenic C. difficile Assay

    FDA UDI
    GREAT BASIN SCIENTIFIC, INC.·B178GBCDIFF100·C. diff Assay Cartridge and Sample Prep Device.

    Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.

    FDA Recall
    Terminated ·Great Basin Scientific, Inc.·Product code PAM·December 12, 2016

    Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.

    FDA Enforcement
    Class II ·Terminated·Great Basin Scientific, Inc.·January 25, 2017