BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Acucy System

    DI: 00742860100338 · Model: 1039 · SEKISUI DIAGNOSTICS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Acucy System
    Primary DI
    00742860100338
    Version / Model
    1039
    Company Name
    SEKISUI DIAGNOSTICS, LLC
    Labeler DUNS
    966812344
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-24
    Public Version
    4
    Public Version Date
    2026-02-24
    Public Version Status
    Update
    Public Device Record Key
    87305a6f-26b9-4e80-a161-d64e40b2d6bf

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PSZ Devices Detecting Influenza A, B, And C Virus Antigens

    GMDN Terms

    Code Name
    42625 Photometric/spectroscopic immunoassay analyser IVD

    Identifiers

    Type ID
    Primary 00742860100338