BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ImmunoCard Toxins A & B

    DI: 00840733101786 · Model: 712050 · MERIDIAN BIOSCIENCE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ImmunoCard Toxins A & B
    Primary DI
    00840733101786
    Version / Model
    712050
    Catalog Number
    712050
    Company Name
    MERIDIAN BIOSCIENCE, INC.
    Labeler DUNS
    092815364
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-21
    Public Version
    1
    Public Version Date
    2020-09-29
    Public Version Status
    New
    Public Device Record Key
    a9b7567b-7574-4272-a0b3-36e10502a2e7

    Device Description

    ImmunoCard Toxins A & B is a rapid, qualitative, horizontal-flow enzyme immunoassay (EIA) for detecting Clostridium difficile Toxins A and B in human stool. This assay is used as an aid in the diagnosis of C. difficile-associated disease. In the US, ImmunoCard Toxins A & B is not intended for point-of-care use. The device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    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
    LLH Reagents, Clostridium Difficile Toxin

    GMDN Terms

    Code Name
    50832 Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00840733101786

    Customer Contacts

    Phone
    5132713700
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K041003 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius