BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ACCURUN®

    DI: 00816784020291 · Model: 2015-0071 · 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
    00816784020291
    Version / Model
    2015-0071
    Catalog Number
    2015-0071
    Company Name
    Lgc Clinical Diagnostics, Inc.
    Labeler DUNS
    106267123
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-24
    Public Version
    3
    Public Version Date
    2023-08-03
    Public Version Status
    Update
    Public Device Record Key
    a8bdc4ab-0175-4c77-a3a0-d6a9fe31657d

    Device Description

    ACCURUN 117 Hepatitis B e Antigen 1 x 5.0 mL

    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
    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
    42008 Hepatitis B virus e-antigen IVD, control

    Identifiers

    Type ID
    Primary 00816784020291

    Premarket Submissions

    Submission Number Supplement Number
    K972048 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -30 – -10 Degrees Celsius