BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Sunquest Laboratory

    DI: B236LAB11020 · Model: 11.0.2 · CliniSys, Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Sunquest Laboratory
    Primary DI
    B236LAB11020
    Version / Model
    11.0.2
    Company Name
    CliniSys, Inc
    Labeler DUNS
    052934841
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-21
    Public Version
    2
    Public Version Date
    2024-07-22
    Public Version Status
    Update
    Public Device Record Key
    ee10f2e5-d95e-4ed8-b35c-f3686cb3d705
    Distribution End Date
    2024-02-27

    Device Description

    Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via user defined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data

    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 B236LAB11020