BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OSOM ULTRA PLUS FLU A&B Control Kit

    DI: 00742860100406 · Model: 1034 · SEKISUI DIAGNOSTICS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    OSOM ULTRA PLUS FLU A&B Control Kit
    Primary DI
    00742860100406
    Version / Model
    1034
    Company Name
    SEKISUI DIAGNOSTICS, LLC
    Labeler DUNS
    966812344
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2020-06-01
    Public Version
    1
    Public Version Date
    2020-06-09
    Public Version Status
    New
    Public Device Record Key
    275535d8-5842-4e59-a3bd-605b5dd22950

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    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
    49121 Influenza A/B virus antigen IVD, control

    Identifiers

    Type ID
    Unit of Use 10742860100403
    Primary 00742860100406