BEUDAMED
    11 results · 31ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Open, Classified ×

    FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·July 20, 2022

    therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·July 20, 2022

    EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code JJH·March 4, 2024

    QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code JJH·June 3, 2024

    therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·February 25, 2022

    therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·February 25, 2022

    QIAcube Connect MDx, Model No. 9003070

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code JJH·November 21, 2021

    QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code QLT·April 28, 2023

    Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code QOF·March 12, 2025

    QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It is intended to be used only in combination with QIAsymphony kits indicated for use with the QIAsymphony SP for the applications described in the kit handbooks. The QIAsymphony SP is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAsymphony SP instrument

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code JJH·July 2, 2019

    therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·July 20, 2022