BEUDAMED
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    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