BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Tosoh Hi-Tec, Inc.

    Reg #: 3004529019 · FEI: 3004529019 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    36
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    Tosoh Hi-Tec, Inc.
    Registration Number
    3004529019
    FEI Number
    3004529019
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1-37 Fukugawa Minami-machi, Shunan-shi
    City
    Yamaguchi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K971103

    Owner / Operator

    Firm Name
    TOSOH BIOSCIENCE
    Operator Number
    8031673
    Address
    3600 Gantz Road
    City
    Grove City
    State
    OH
    Postal Code
    43123
    Country
    US
    Correspondent
    Isabelle Lang-Zwosta

    US Agent

    Business Name
    Tosoh Bioscience Inc.
    Contact Name
    Isabelle Lang-Zwosta
    Address
    3600 Gantz Rd
    City
    Grove City
    State
    OH
    ZIP
    43123
    Country
    US
    Email
    [email protected]
    Phone
    615 8064671

    Products

    Device Name Product Code
    Fluorometer, For Clinical Use KHO
    Hemoglobin A1c Test System PDJ
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Hemoglobin A2 Quantitation JPD
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Assay, Glycosylated Hemoglobin LCP
    Calibrator, Primary JIS

    Proprietary Names

    Automated Immunoassay Analyzer AIA-2000 Automated Immunoassay Analyzer AIA-360 Automated Immunoassay Analyzer AIA-900 G11 Variant Elution Buffer No. 3 Tosoh Automated Glycohemoglobin Analyzer HLC-723G11 LA G11 Variant Elution Buffer No. 1 Tosoh Automated Glycohemoglobin Analyzer HLC-723G11 HLC-723G11 TSKgel G11 Variant G11 90 SL G11 Variant Elution Buffer No. 2 HEMOGLOBIN A1c Control SET Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 LA G8 F&A2 Calibrator Set TSKgel G8 ?-thal HLC-723G8 G8 90 SL G8 ?-thal Elution Buffer Kit AIA®-CL300 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER AIA®-CL2400 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER AIA®-CL1200 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER HLC-723 GR01 Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 GR01 G8 Variant Elution Buffer No. 3 HbA1c Calibrator Set TSKgel G8 Variant G8 Variant Elution Buffer No. 1 G8 Variant Elution Buffer No. 2 TSKgel GX HLC-723GX GX Elution Buffer No. 1 GX Elution Buffer No. 2 Tosoh Automated Glycohemoglobin Analyzer HLC-723GX GX Elution Buffer No. 3

    Establishment Types

    Manufacture Medical Device