10 results
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32ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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QIAGEN GmbH
Manufacturer
🇩🇪 Germany·TÜV Rheinland LGA Products GmbH
QIAGEN, GMBH
FDA registration
QIAGEN, GMBH·16 products·🇩🇪 Germany
QIAGEN GmbH
Authorized representative
🇩🇪 Germany·2 Manufacturers
HX 1782924-1
Certificate
IVDR QMS·QIAGEN GmbH·TÜV Rheinland LGA Products GmbH
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