BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Sunquest Laboratory

    DI: B236LAB10010 · Model: 10.0.1 · 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
    B236LAB10010
    Version / Model
    10.0.1
    Company Name
    CliniSys, Inc
    Labeler DUNS
    052934841
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-05
    Public Version
    3
    Public Version Date
    2025-06-05
    Public Version Status
    Update
    Public Device Record Key
    885236aa-c7c6-40cf-9d42-9216dc7b9ad9
    Distribution End Date
    2022-06-23

    Device Description

    Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. 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 B236LAB10010