BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    uTASWako AFP-L3 Control L and H

    Reg #: 3003522182 · FEI: 3003522182 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    FUJIFILM Healthcare Manufacturing Corporation MIE Office
    Registration Number
    3003522182
    FEI Number
    3003522182
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2613-2, Oaza Ogohara
    City
    Komono-cho, Mie-gun
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K100464

    Owner / Operator

    Firm Name
    FUJIFILM Wako Pure Chemical Corporation
    Operator Number
    8030234
    Address
    1-2 Doshomachi 3-Chome
    City
    Chuo-Ku
    State
    Osaka
    Postal Code
    540-8605
    Country
    JP

    US Agent

    Business Name
    FUJIFILM Healthcare Americas Corporation
    Contact Name
    Randy Vader
    Address
    81 Hartwell Ave Ste 300
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US
    Email
    [email protected]
    Phone
    360 3566821

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma OAU
    Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment NSF
    Calibrator, Secondary JIT
    Micro Total Analysis Instrument System OUE

    Proprietary Names

    uTASWako AFP-L3 Control L and H uTASWako AFP-L3 Sample Dilution Buffer uTASWako AFP-L3 Immunological Test System uTASWako DCP Immunological Test System uTASWako AFP-L3 Calibrator Set uTASWako DCP Control L and H uTASWako DCP Calibrator Set uTASWako i30 Immunoanalyzer System uTASWako Chip Cassette uTASWako Wash Solution

    Establishment Types

    Manufacture Medical Device