BEUDAMED
    2 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories Inc. (St Jude Medical)·June 23, 2021

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015