BEUDAMED
    30 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    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

    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

    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

    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

    QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223

    FDA Enforcement
    Class II ·Ongoing·Qiagen GmbH·August 2, 2023

    QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223

    FDA Enforcement
    Class II ·Ongoing·Qiagen GmbH·August 2, 2023

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214

    FDA Enforcement
    Class II ·Ongoing·Qiagen GmbH·August 2, 2023

    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

    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