BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BD CTGCTV2

    K Number: K243343 · Decision Apr 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    179

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    Basic Information

    Device Name
    BD CTGCTV2
    K Number
    K243343
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3393
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bd Integrated Diagnostic Solutions/Becton,
    Date Received
    October 25, 2024
    Decision Date
    April 22, 2025
    Product Code
    QEP
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections

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