BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Tosoh ST AIA-PACK HbA1c

    Reg #: 9612316 · FEI: 3002808328 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    TOSOH AIA, INC.
    Registration Number
    9612316
    FEI Number
    3002808328
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2, IWASEKOSHI-MACHI
    City
    TOYAMA
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K100304

    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
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Assay, Glycosylated Hemoglobin LCP
    Calibrator, Secondary JIT

    Proprietary Names

    Tosoh ST AIA-PACK HbA1c

    Establishment Types

    Manufacture Medical Device