BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Sunquest Mitogen LIMS

    DI: B236LIMS3410 · Model: 3.4.1 · CliniSys, Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sunquest Mitogen LIMS
    Primary DI
    B236LIMS3410
    Version / Model
    3.4.1
    Company Name
    CliniSys, Inc
    Labeler DUNS
    052934841
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-04-20
    Public Version
    3
    Public Version Date
    2023-07-24
    Public Version Status
    Update
    Public Device Record Key
    14fce218-a3e0-4ef3-b5f9-7fc540bffca7
    Distribution End Date
    2021-06-21

    Device Description

    Sunquest Mitogen™ LIMS supports clinical laboratories in the management of laboratory workflow (order entry through reporting) and to transfer, store, and display test results and information.

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JQP Calculator/Data Processing Module, For Clinical Use

    GMDN Terms

    Code Name
    44082 Clinical laboratory information system application software

    Identifiers

    Type ID
    Primary B236LIMS3410