BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Liquichek

    DI: 00847661000662 · Model: 645 · BIO-RAD LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Liquichek
    Primary DI
    00847661000662
    Version / Model
    645
    Catalog Number
    645
    Company Name
    BIO-RAD LABORATORIES, INC.
    Labeler DUNS
    051624070
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-09
    Public Version
    5
    Public Version Date
    2023-01-31
    Public Version Status
    Update
    Public Device Record Key
    c8ecd034-9afe-4cec-b19c-0dae73ee4aa2

    Device Description

    Liquichek Cardiac Markers Control LT Trilevel (A human serum 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
    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
    JJY Multi-analyte controls, all kinds (assayed)

    GMDN Terms

    Code Name
    47016 Multiple cardiac marker IVD, control

    Identifiers

    Type ID
    Primary 00847661000662

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K040277 000

    Storage Conditions

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