BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ACCURUN BKV DNA Positive Control

    DI: 00850041090146 · Model: 2020-0209 · Lgc Clinical Diagnostics, Inc.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ACCURUN BKV DNA Positive Control
    Primary DI
    00850041090146
    Version / Model
    2020-0209
    Company Name
    Lgc Clinical Diagnostics, Inc.
    Labeler DUNS
    106267123
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-11-21
    Public Version
    1
    Public Version Date
    2025-12-01
    Public Version Status
    New
    Public Device Record Key
    c9df95c9-1f62-43fa-a608-5995d218ad33

    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    49849 BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00850041090146