BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Human Reference Standard

    DI: B1761876 · Model: 1 · KENT LABORATORIES INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Human Reference Standard
    Primary DI
    B1761876
    Version / Model
    1
    Catalog Number
    1876
    Company Name
    KENT LABORATORIES INC
    Labeler DUNS
    093642254
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    f71d4833-0485-4e02-b26f-a5e0c2893bc6

    Device Description

    Calibrated Human Reference standards

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DGR Whole Human Serum, Antigen, Antiserum, Control

    GMDN Terms

    Code Name
    30506 Plasma protein IVD, control

    Identifiers

    Type ID
    Primary B1761876