BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QC Sets and Panels: Helix Elite™

    DI: 70845357044432 · Model: 8269 · MICROBIOLOGICS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    QC Sets and Panels: Helix Elite™
    Primary DI
    70845357044432
    Version / Model
    8269
    Catalog Number
    8269
    Company Name
    MICROBIOLOGICS INC.
    Labeler DUNS
    060467826
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-02-10
    Public Version
    1
    Public Version Date
    2026-02-18
    Public Version Status
    New
    Public Device Record Key
    2cec5286-ab33-41e4-a451-ba67b690441d

    Device Characteristics

    Single Use
    Yes
    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
    47279 Influenza A/B virus nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 70845357044432