BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ACCURUN®

    DI: 00816784020581 · Model: 2020-0095 · 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
    00816784020581
    Version / Model
    2020-0095
    Catalog Number
    2020-0095
    Company Name
    Lgc Clinical Diagnostics, Inc.
    Labeler DUNS
    106267123
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    6
    Public Version Date
    2023-07-25
    Public Version Status
    Update
    Public Device Record Key
    40a27108-dfc8-4eb0-922d-81ff7ab1f17b

    Device Description

    ACCURUN 325 Series 370 HBV DNA Positive Control 5 x 0.6 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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    41992 Hepatitis B virus nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 00816784020581

    Premarket Submissions

    Submission Number Supplement Number
    BK040064 0

    Storage Conditions

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