BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ImmunoCard STAT! EHEC

    DI: 00840733101366 · Model: 751630 · 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 STAT! EHEC
    Primary DI
    00840733101366
    Version / Model
    751630
    Catalog Number
    751630
    Company Name
    MERIDIAN BIOSCIENCE, INC.
    Labeler DUNS
    092815364
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-11-21
    Public Version
    1
    Public Version Date
    2019-11-29
    Public Version Status
    New
    Public Device Record Key
    14a92675-1b47-4c05-81ea-03ee3bca1038

    Device Description

    ImmunoCard STAT! EHEC is an immunochromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coli in cultures derived from clinical stool specimens. ImmunoCard STAT! EHEC is used in conjunction with the patient’s clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. coli (EHEC) infections.

    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
    GMZ Antigens, All Types, Escherichia Coli

    GMDN Terms

    Code Name
    50927 Escherichia coli antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00840733101366

    Premarket Submissions

    Submission Number Supplement Number
    K062546 000