BEUDAMED
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    ARC 400

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)

    FDA Enforcement
    Class II ·Ongoing·Qiagen GmbH·October 11, 2023

    MRC Systems GmbH Medizintechnische Systeme

    Importer
    🇩🇪 Germany

    MedNet EC-REP IIb GmbH

    Authorized representative
    🇩🇪 Germany·32 Manufacturers·165 Devices

    KTR Europe GmbH

    Authorized representative
    🇩🇪 Germany·135 Manufacturers·3461 Devices