BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Evidence MultiSTAT DOA Urine MultiPlex

    DI: 05055273216752 · Model: EV4393 · RANDOX LABORATORIES LIMITED
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Evidence MultiSTAT DOA Urine MultiPlex
    Primary DI
    05055273216752
    Version / Model
    EV4393
    Catalog Number
    EV4393
    Company Name
    RANDOX LABORATORIES LIMITED
    Labeler DUNS
    227530649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-09-16
    Public Version
    1
    Public Version Date
    2024-09-24
    Public Version Status
    New
    Public Device Record Key
    5105e85f-03a5-4989-8483-8dc17df01e9c

    Device Description

    The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cut offs.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    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
    DIS Enzyme Immunoassay, Barbiturate
    DJG Enzyme Immunoassay, Opiates
    LCM Enzyme Immunoassay, Phencyclidine

    GMDN Terms

    Code Name
    58886 Multiple drugs of abuse IVD, kit, multiplex

    Identifiers

    Type ID
    Primary 05055273216752

    Customer Contacts

    Phone
    +442894451070
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K221550 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius