BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Fujirebio Inc. Ube Facility

    Reg #: 3014643041 · FEI: 3014643041 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    Fujirebio Inc. Ube Facility
    Registration Number
    3014643041
    FEI Number
    3014643041
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    203-152, Aza-Ushiake, Oaza-Yoshiwa, Ube-shi
    City
    Yamaguchi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K142895

    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
    Calibrator, Secondary JIT
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) LTK
    Antigens, Ha, Treponema Pallidum GMT
    System, Test, Automated Blood Grouping And Antibody KSZ
    Test, Donor, Cmv MZE

    Proprietary Names

    Lumipulse G CA125II Calibrators Lumipulse G CA125II IC Lumipulse G Wash Solution 4008248 Lumipulse G1200 Instrument Lumipulse G Wash Solution 231173 Substrate Solutions Lumipulse G Dilution Cartridges Soda Lime for Lumipulse System Specimen Diluent 1 Serodia TP-PA Serodia TP-PA Kits 234952 Serodia TP-PA Kits 234976 PK CMV-PA System

    Establishment Types

    Manufacture Medical Device