BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Solana Instrument

    Reg #: 3008713179 · FEI: 3008713179 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Dialunox GmbH
    Registration Number
    3008713179
    FEI Number
    3008713179
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bodenseeallee 20
    City
    Stockach Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K150868

    Owner / Operator

    Firm Name
    Dialunox GmbH
    Operator Number
    10049882
    Address
    Bodenseeallee 20
    City
    Stockach
    State
    DE-NOTA
    Postal Code
    78333
    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
    Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System PGX

    Proprietary Names

    Solana Instrument

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)