BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    RIDA®GENE Norovirus GI/GII

    Reg #: 3004061467 · FEI: 3004061467 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    R-BIOPHARM AG
    Registration Number
    3004061467
    FEI Number
    3004061467
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    An der neuen Bergstrasse 17
    City
    DARMSTADT Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K171511

    Owner / Operator

    Firm Name
    R-BIOPHARM AG
    Operator Number
    9058209
    Address
    An der neuen Bergstrasse 17, --
    City
    Darmstadt
    State
    Hesse
    Postal Code
    D-64297
    Country
    DE
    Correspondent
    Fernanda Heiss

    US Agent

    Business Name
    AusDiagnostics USA Inc
    Contact Name
    Kevin Fernander
    Address
    1367 Brumlow Ave
    City
    Southlake
    State
    TX
    ZIP
    76092
    Country
    US
    Email
    [email protected]
    Phone
    817 9121448

    Products

    Device Name Product Code
    Reagents For Detection Of Norovirus Nucleic Acid PIQ
    Real Time Nucleic Acid Amplification System OOI

    Proprietary Names

    RIDA®GENE Norovirus GI/GII

    Establishment Types

    Manufacture Medical Device