BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Borrelia B31 IgM ViraStripe

    Reg #: 3004181478 · FEI: 3004181478 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VIRAMED BIOTECH AG
    Registration Number
    3004181478
    FEI Number
    3004181478
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BEHRINGSTRASSE 11
    City
    PLANEGG Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K082329

    Owner / Operator

    Firm Name
    VIRAMED BIOTECH AG
    Operator Number
    9062838
    Address
    BEHRINGSTRASSE 11, --
    City
    PLANEGG
    State
    DE-NOTA
    Postal Code
    D-82152
    Country
    DE

    US Agent

    Business Name
    Viralab Inc
    Contact Name
    Leonard Rollins
    Address
    1815 14th St. NW Suite D
    City
    Rochester
    State
    MN
    ZIP
    55901
    Country
    US
    Email
    [email protected]
    Phone
    507 2084044

    Products

    Device Name Product Code
    Reagent, Borrelia Serological Reagent LSR

    Proprietary Names

    Borrelia B31 IgM ViraStripe

    Establishment Types

    Manufacture Medical Device