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Qiagen GmbH

4 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx i recall (Z-2665-2023)Qiagen GmbH2023-09-29
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing na recall (Z-2245-2023)Qiagen GmbH2023-07-27
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US recall (Z-2246-2023)Qiagen GmbH2023-07-27
QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiatio recall (Z-2215-2023)Qiagen GmbH2023-07-21

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Every clearance here is in the API, with alerts when new ones post.