BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Diomni™ Software, Version 4.0.0

    DI: 10190302019408 · Model: A58343 · LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Diomni™ Software, Version 4.0.0
    Primary DI
    10190302019408
    Version / Model
    A58343
    Company Name
    LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
    Labeler DUNS
    628548377
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-12
    Public Version
    1
    Public Version Date
    2023-07-20
    Public Version Status
    New
    Public Device Record Key
    6950e4f8-3444-43bc-b76b-7f8f8fc39931

    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
    Yes
    Has Serial Number
    No
    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
    OOI real time Nucleic acid amplification system

    GMDN Terms

    Code Name
    43472 Laboratory instrument/analyser application software IVD

    Identifiers

    Type ID
    Primary 10190302019408