BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ImmunoCard STAT E. coli O157 Plus

    DI: 00840733101816 · Model: 750530 · MERIDIAN BIOSCIENCE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ImmunoCard STAT E. coli O157 Plus
    Primary DI
    00840733101816
    Version / Model
    750530
    Catalog Number
    750530
    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
    b1fa9f3d-1096-4ec3-9038-9921675cd506

    Device Description

    The ImmunoCard STAT E. coli O157 Plus is a rapid test for the detection of antigens from Shiga toxin-production E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, stool in modified Cary-Blair medium or confirmatory stool cultures grown in MacConkey broth of sorbitol MacConkey (SMAC) plates. In the US, ImmunoCard STAT E. coli O157 Plus is not intended for point-of-care use. This 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
    GMZ Antigens, All Types, Escherichia Coli

    GMDN Terms

    Code Name
    50923 Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00840733101816

    Customer Contacts

    Phone
    5132713700
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K023599 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius