BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    chromID® CPS® Elite Agar CPSO

    DI: 03573026600402 · Model: chromID® CPS® Elite Agar CPSO · BIOMERIEUX SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    10

    Basic Information

    Brand Name
    chromID® CPS® Elite Agar CPSO
    Primary DI
    03573026600402
    Version / Model
    chromID® CPS® Elite Agar CPSO
    Company Name
    BIOMERIEUX SA
    Labeler DUNS
    276816717
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2020-05-19
    Public Version
    1
    Public Version Date
    2020-05-27
    Public Version Status
    New
    Public Device Record Key
    7bbdcfea-bc16-4596-bf9d-d442f5449756

    Device Description

    Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JXA KIT, SCREENING, URINE

    GMDN Terms

    Code Name
    58585 Differential/selective agar culture medium IVD

    Identifiers

    Type ID
    Package 03573026468170
    Primary 03573026600402
    Unit of Use 03573026600419
    Package 03573026443917

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius