BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Alinity i HE4 Reagents

    Reg #: 2521625 · FEI: 2521625 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Fujirebio Diagnostics, Inc.
    Registration Number
    2521625
    FEI Number
    2521625
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    201 Great Valley Parkway
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093957

    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

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Test, Epithelial Ovarian Tumor Associated Antigen (He4) OIU
    Calibrator, Secondary JIT

    Proprietary Names

    Alinity i HE4 Reagents ARCHITECT HE4 Reagents ARCHITECT HE4 Controls ARCHITECT HE4 Calibrators Alinity i HE4 Calibrators Alinity i HE4 Controls

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)