BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ACCURUN®

    DI: 00850041090047 · Model: 2020-0155 · Lgc Clinical Diagnostics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ACCURUN®
    Primary DI
    00850041090047
    Version / Model
    2020-0155
    Catalog Number
    2020-0155
    Company Name
    Lgc Clinical Diagnostics, Inc.
    Labeler DUNS
    106267123
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-20
    Public Version
    1
    Public Version Date
    2023-10-30
    Public Version Status
    New
    Public Device Record Key
    c5438eb1-6baa-4359-a225-3e9430148ae2

    Device Description

    ACCURUN Babesia Molecular Controls Kit

    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
    OHQ Multi-Analyte Controls Unassayed

    GMDN Terms

    Code Name
    52139 Babesia microti nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 00850041090047