BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    ST AIA-PACK AFP

    Reg #: 8031673 · FEI: 2967 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TOSOH CORP.
    Registration Number
    8031673
    FEI Number
    2967
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2-2-1 Yaesu
    City
    Chuo-ku Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K023894

    Owner / Operator

    Firm Name
    TOSOH BIOSCIENCE
    Operator Number
    8031673
    Address
    3600 Gantz Road
    City
    Grove City
    State
    OH
    Postal Code
    43123
    Country
    US
    Correspondent
    Joshua D Levin

    US Agent

    Business Name
    Tosoh Bioscience Inc.
    Contact Name
    Dave Wurtz
    Address
    3600 Gantz Road
    City
    Grove City
    State
    OH
    ZIP
    43123
    Country
    US
    Email
    [email protected]
    Phone
    415 6354762

    Products

    Device Name Product Code
    Kit, Test,Alpha-Fetoprotein For Testicular Cancer LOJ
    Calibrator, Primary JIS

    Proprietary Names

    ST AIA-PACK AFP ST AIA-PACK AFP CALIBRATOR SET,ST AIA-PACK AFP SAMPLE DILUTING SOLUTION

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device