BEUDAMED
    15 results · 19ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    SARS-CoV-2 Antigen Test

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

    QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).

    FDA Enforcement
    Class II ·Terminated·QIAGEN Gaithersburg, Inc.·May 22, 2013

    QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook.

    FDA Enforcement
    Class II ·Terminated·QIAGEN Gaithersburg, Inc.·May 22, 2013

    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

    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

    Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·September 22, 2021

    EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·QIAGEN·August 8, 2018

    QIAamp DSP Virus Kit Cat. No. 60704

    FDA Enforcement
    Class II ·Terminated·Qiagen, GmbH·December 27, 2017

    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

    RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from formalin-fixed, paraffin embedded (FFPE) tissues. The product is intended to be used by professional users, such as technicians and physicians that are trained in molecular biological techniques. It deploys an optimized silica spin-column-based protocol, and includes enzymatic removal of residual DNA. The RNeasy DSP FFPE Kit is intended for in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences, Inc.·July 3, 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