BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    INNO-LiPA HCV 2 Amp 100T, IVD-US

    Reg #: 9615837 · FEI: 3002608770 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Fujirebio Europe N.V.
    Registration Number
    9615837
    FEI Number
    3002608770
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    TECHNOLOGIEPARK 6
    City
    GHENT Oost-Vlaanderen
    Country
    BE

    Regulatory Submissions

    PMA Number
    P160016

    Owner / Operator

    Firm Name
    Fujirebio Diagnostics, Inc.
    Operator Number
    10022860
    Address
    201 Great Valley Parkway
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US
    Correspondent
    Greg Dickson

    US Agent

    Business Name
    Fujirebio Diagnostics, Inc.
    Contact Name
    Greg Dickson
    Address
    201 Great Valley Parkway
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US
    Email
    [email protected]
    Phone
    610 2403888

    Products

    Device Name Product Code
    Assay, Genotyping, Hepatitis C Virus OBF

    Proprietary Names

    INNO-LiPA HCV 2 Amp 100T, IVD-US INNO-LiPA HCV 2 Genotyping 40T, IVD-US INNO-LiPA HCV 2 Control 6T, IVD-US LiRAS for LiPA HCV v1 IVD-US INNO-LiPA HCV 2 Amp 40T, IVD-US INNO-LiPA HCV 2 Genotyping 100T, IVD-US

    Establishment Types

    Manufacture Medical Device