15 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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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
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
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
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