BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Macro & Micro-Test Fluorescence Immunoassay Analyzer

    DI: 06974849369380 · Model: HWTS-IF1000 · Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Macro & Micro-Test Fluorescence Immunoassay Analyzer
    Primary DI
    06974849369380
    Version / Model
    HWTS-IF1000
    Company Name
    Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
    Labeler DUNS
    560300737
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-09-19
    Public Version
    1
    Public Version Date
    2024-09-27
    Public Version Status
    New
    Public Device Record Key
    4694d44f-d357-4e61-ab9d-517f0d63458a

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KHO Fluorometer, For Clinical Use

    GMDN Terms

    Code Name
    56705 Fluorescent immunoassay analyser IVD, laboratory

    Identifiers

    Type ID
    Primary 06974849369380