BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    QIAstat-Dx Meningitis/Encephalitis (ME) Panel

    K Number: K242256 · Decision Oct 29, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    13
    Review Days
    90

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    Basic Information

    Device Name
    QIAstat-Dx Meningitis/Encephalitis (ME) Panel
    K Number
    K242256
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3970
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    QIAGEN GmbH
    Date Received
    July 31, 2024
    Decision Date
    October 29, 2024
    Product Code
    PLO
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

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    Other Clearances by QIAGEN GmbH

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    K233100 QIAstat-Dx® Respiratory Panel Plus
    K183597 QIAstat-Dx Respiratory Panel
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