BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)

    Reg #: 3003419906 · FEI: 3003419906 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)
    Registration Number
    3003419906
    FEI Number
    3003419906
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6-1 Takata-cho
    City
    Amagasaki-shi Hyogo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K963847

    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 100
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US
    Email
    [email protected]
    Phone
    360 3566821

    Products

    Device Name Product Code
    Ldl & Vldl Precipitation, Hdl LBR
    Calibrator, Primary JIS
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Titrimetric, Fatty Acids JLH
    Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) JIQ
    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
    System, Test, Low Density, Lipoprotein MRR
    Calibrator, Multi-Analyte Mixture JIX
    Complement C9, Antigen, Antiserum, Control DAE

    Proprietary Names

    L-Type HDL-C Reagent NEFA Linearity Material Complement Control HR SERIES NEFA-HR2 Solvent A HR SERIES NEFA-HR2 Solvent B HR SERIES NEFA-HR2 Color Reagent B HR SERIES NEFA-HR2 Color Reagent A Autokit Micro Albumin Control Set Autokit Micro Albumin Calibrator Set Autokit Micro Albumin Microalbumin Controls Alinity c Microalbumin Calibrators Alinity c Microalbumin Reagent Kit Microalbumin Calibrators Microalbumin Alinity c Microalbumin Controls uTASWako AFP-L3 Sample Dilution Buffer uTASWako DCP Control L and H uTASWako AFP-L3 Immunological Test System uTASWako AFP-L3 Control L and H uTASWako i30 Immunoanalyzer System uTASWako DCP Calibrator Set uTASWako DCP Immunological Test System uTASWako AFP-L3 Calibrator Set uTASWako Chip Cassette uTASWako Wash Solution Wako HDL-C/LDL-C Calibrator L-Type LDL-C Reagent NEFA Standard Solution Multi-Calibrator Lipids CH50 Calibrator AUTOKIT CH50

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility