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    Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·August 14, 2019

    ROSA One 3.1 Brain Application

    FDA Enforcement
    Class II ·Terminated·MEDTECH SAS·February 19, 2020

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022