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    K Number
    K023599
    Device Name
    IMMUNOCARD STAT! E. COLI O157 PLUS
    Manufacturer
    MERIDIAN BIOSCIENCE, INC.
    Date Cleared
    2003-01-03

    (67 days)

    Product Code
    GMZ
    Regulation Number
    866.3255
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IMMUNOCARD STAT! E. COLI O157 PLUS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ImmunoCard STAT! E.coli O157 Plus is a rapid test for the detection of antigens from shiga toxin producing 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 or sorbitol MacConkey (SMAC) plates.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "ImmunoCard STAT! E.coli 0157 Plus" device. It does not contain information regarding
    acceptance criteria, study design, sample sizes, expert qualifications, or ground truth
    details. Therefore, I cannot provide the requested information based on the input text.

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