BEUDAMED
    20 results · 18ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·March 30, 2016

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

    FDA Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·April 9, 2025

    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 Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·July 24, 2024

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

    FDA Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·September 7, 2022

    QIAcube Connect MDx, Model No. 9003070

    FDA Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·September 21, 2022

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

    FDA Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·September 7, 2022

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

    FDA Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·September 7, 2022

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

    FDA Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·April 27, 2022

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

    FDA Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·April 27, 2022

    EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ1 Advanced XL.

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·November 14, 2018

    QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·September 16, 2020

    therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·February 3, 2021

    SARS-CoV-2 Antigen Test

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·February 10, 2021

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

    FDA Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·June 14, 2023

    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 Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·August 28, 2019

    therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·June 17, 2020

    AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box)

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·April 8, 2020

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·January 12, 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 Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·April 17, 2024

    QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·March 18, 2020