BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sensititre

    DI: M578GNID2 · Model: GNID · TREK DIAGNOSTIC SYSTEMS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    Sensititre
    Primary DI
    M578GNID2
    Version / Model
    GNID
    Company Name
    TREK DIAGNOSTIC SYSTEMS LIMITED
    Labeler DUNS
    298203498
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    3e30a69a-408c-4208-8a75-a5d6b8fabc44

    Device Characteristics

    Single Use
    Yes
    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
    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
    LQL Gram Positive Identification Panel

    GMDN Terms

    Code Name
    40372 Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, kit

    Identifiers

    Type ID
    Primary M578GNID2
    Unit of Use M578GNID0

    Customer Contacts

    Phone
    8006427029
    Email
    [email protected]