BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls Kit

    DI: 00860006589714 · Model: 0505-0260 · Lgc Clinical Diagnostics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls Kit
    Primary DI
    00860006589714
    Version / Model
    0505-0260
    Company Name
    Lgc Clinical Diagnostics, Inc.
    Labeler DUNS
    106267123
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-17
    Public Version
    2
    Public Version Date
    2023-12-18
    Public Version Status
    Update
    Public Device Record Key
    d7d6d20d-9b23-4caa-890c-0f05a59a1a47

    Device Description

    AccuPlex SARS-CoV-2, Flu A/B, and RSV 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
    Yes
    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
    47920 Multiple-genus respiratory virus nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 00860006589714