BEUDAMED
    3 results · 7ms · Sources: EU EUDAMED, US FDA

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    Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·April 17, 2019

    Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·April 17, 2019

    Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·April 17, 2019