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

    Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

    K Number: K242109 · Decision Jan 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    10
    Applicant Total
    10
    Review Days
    180

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    Basic Information

    Device Name
    Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
    K Number
    K242109
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    866.3981
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cepheid®
    Date Received
    July 19, 2024
    Decision Date
    January 15, 2025
    Product Code
    QQX
    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
    QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

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    Other Clearances by Cepheid®

    K Number Device Name
    K250995 Xpert Xpress CoV-2/Flu/RSV plus
    K250996 Xpert Xpress CoV-2/Flu/RSV plus
    K243730 Xpert C. difficile/Epi
    K243625 Xpert MRSA/SA SSTI
    K243405 Xpert vanA
    K243070 Xpert® SA Nasal Complete
    K230440 Xpert® Xpress CoV-2 plus
    K231481 Xpert Xpress CoV-2/Flu/RSV plus
    K223046 Xpert® FII & FV