BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Autokit Micro Albumin Calibrator Set

    Reg #: 3003419906 · FEI: 3003419906 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)
    Registration Number
    3003419906
    FEI Number
    3003419906
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6-1 Takata-cho
    City
    Amagasaki-shi Hyogo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K030320

    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
    Calibrator, Primary JIS
    Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) JIQ
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    Autokit Micro Albumin Calibrator Set Autokit Micro Albumin Autokit Micro Albumin Control Set Microalbumin Controls Alinity c Microalbumin Reagent Kit Alinity c Microalbumin Calibrators Alinity c Microalbumin Controls Microalbumin Microalbumin Calibrators

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility