BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CRL STAT Dip Card

    DI: 00817815021294 · Model: KCUR920106 · CLINICAL REFERENCE LABORATORY, INC.
    View on AccessGUDID
    Product Codes
    5
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CRL STAT Dip Card
    Primary DI
    00817815021294
    Version / Model
    KCUR920106
    Company Name
    CLINICAL REFERENCE LABORATORY, INC.
    Labeler DUNS
    098268311
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-23
    Public Version
    1
    Public Version Date
    2023-08-31
    Public Version Status
    New
    Public Device Record Key
    0ea4c213-55a3-4e2d-ba01-9be8e044265b

    Device Description

    CRL STAT 5 panel Dip - KCUR920106 AMP1000/COC300/OPI2000/PCP25/THC50

    Device Characteristics

    Single Use
    Yes
    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
    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
    DKZ Enzyme Immunoassay, Amphetamine
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
    DJG Enzyme Immunoassay, Opiates
    LCM Enzyme Immunoassay, Phencyclidine
    LDJ Enzyme Immunoassay, Cannabinoids

    GMDN Terms

    Code Name
    46994 Multiple drugs of abuse IVD, kit, rapid ICT, clinical

    Identifiers

    Type ID
    Primary 00817815021294