BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QC Sets and Panels: Helix Elite™

    DI: 70845357043749 · Model: 8250 · MICROBIOLOGICS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    QC Sets and Panels: Helix Elite™
    Primary DI
    70845357043749
    Version / Model
    8250
    Catalog Number
    8250
    Company Name
    MICROBIOLOGICS INC.
    Labeler DUNS
    060467826
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-16
    Public Version
    1
    Public Version Date
    2022-02-24
    Public Version Status
    New
    Public Device Record Key
    ec4c435f-7ba8-4da1-a5ef-fda2cd6fb141

    Device Description

    Helix Elite™ Molecular Standards Candida vaginitis/Trichomonas vaginalis (CV/TV) Control Panel

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    48210 Multiple-type vaginitis-associated organism nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 70845357043749

    Customer Contacts

    Phone
    +1(320)253-7400
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 25 Degrees Celsius