BEUDAMED
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    Filters Classification: Class Iii ×

    LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification

    FDA Enforcement
    Class III ·Terminated·LumiraDx·November 2, 2022

    PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.

    FDA Enforcement
    Class III ·Terminated·DNA Genotek Inc.·September 30, 2020