BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BILIRUBIN ELEVATED SERUM (BIL CONTROL H)

    DI: 05055273200706 · Model: BE454 · RANDOX LABORATORIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BILIRUBIN ELEVATED SERUM (BIL CONTROL H)
    Primary DI
    05055273200706
    Version / Model
    BE454
    Company Name
    RANDOX LABORATORIES LIMITED
    Labeler DUNS
    227530649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-03
    Public Version
    1
    Public Version Date
    2019-06-11
    Public Version Status
    New
    Public Device Record Key
    180634b8-1eee-4cdf-944f-0c1bbe3a62a0

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    GMDN Terms

    Code Name
    30215 Total bilirubin IVD, control

    Identifiers

    Type ID
    Primary 05055273200706