BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    QIAstat-Dx Respiratory Panel Plus

    Reg #: 3004013603 · FEI: 3004013603 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    QIAGEN, GMBH
    Registration Number
    3004013603
    FEI Number
    3004013603
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    QIAGEN STRASSE 1
    City
    HILDEN North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K233100

    Owner / Operator

    Firm Name
    QIAGEN, GmbH
    Operator Number
    9065957
    Address
    QIAGEN STRASSE 1, --
    City
    HILDEN
    State
    DE-NOTA
    Postal Code
    40724
    Country
    DE

    US Agent

    Business Name
    QIAGEN
    Contact Name
    Kristen Kanack
    Address
    19300 Germantown Rd.
    City
    Germantown
    State
    MD
    ZIP
    20874
    Country
    US
    Email
    [email protected]
    Phone
    240 5060706

    Products

    Device Name Product Code
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF

    Proprietary Names

    QIAstat-Dx Respiratory Panel Plus QIAstat-Dx Respiratory Panel Mini

    Establishment Types

    Manufacture Medical Device