BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test

    Reg #: 9611882 · FEI: 3002808078 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SSI Diagnostica A/S
    Registration Number
    9611882
    FEI Number
    3002808078
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Herredsvejen
    City
    Hilleroed Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K191184

    Owner / Operator

    Firm Name
    SSI Diagnostica A/S
    Operator Number
    10052749
    Address
    Herredsvejen 2
    City
    Hilleroed
    State
    Hovedstaden
    Postal Code
    3400
    Country
    DK

    US Agent

    Business Name
    TECHLAB
    Contact Name
    Donna Link
    Address
    2001 Kraft Drive
    City
    Blacksburg
    State
    VA
    ZIP
    24060
    Country
    US
    Email
    [email protected]
    Phone
    800 8324522

    Products

    Device Name Product Code
    Legionella, Spp., Elisa MJH
    Antisera, All Groups, Streptococcus Spp. GTZ

    Proprietary Names

    ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test

    Establishment Types

    Manufacture Medical Device