BEUDAMED
    6 results · 35ms · Sources: EU EUDAMED, US FDA

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    Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB

    FDA Recall
    Open, Classified ·AURIS HEALTH INC·Product code FGB·August 2, 2024

    Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code NSU·April 22, 2019

    Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OOI·April 5, 2022

    VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·December 10, 2018

    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Recall
    Terminated ·Luminex Corporation·Product code PAM·October 13, 2020

    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Recall
    Terminated ·Luminex Corporation·Product code PEN·October 13, 2020