BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    InteliQ

    DI: 03610522248902 · Model: 12016487 · BIO-RAD LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    InteliQ
    Primary DI
    03610522248902
    Version / Model
    12016487
    Catalog Number
    12016487
    Company Name
    BIO-RAD LABORATORIES, INC.
    Labeler DUNS
    051624070
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-31
    Public Version
    1
    Public Version Date
    2023-02-08
    Public Version Status
    New
    Public Device Record Key
    571ae296-407b-4483-b56b-9ae779794993

    Device Description

    InteliQ Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)

    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
    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
    JJY Multi-analyte controls, all kinds (assayed)

    GMDN Terms

    Code Name
    47016 Multiple cardiac marker IVD, control

    Identifiers

    Type ID
    Primary 03610522248902

    Customer Contacts

    Phone
    +1(800)854-6737
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -70 – -20 Degrees Celsius