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

    Xpert HCV; GeneXpert Xpress System

    K Number: DEN240016 · Decision Jun 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    50
    Review Days
    72

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    Basic Information

    Device Name
    Xpert HCV; GeneXpert Xpress System
    K Number
    DEN240016
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.3171
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Cepheid
    Date Received
    April 16, 2024
    Decision Date
    June 27, 2024
    Product Code
    SBP
    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
    SBP Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test

    Other Clearances by Cepheid

    K Number Device Name
    K253653 Xpert Hemorrhagic Fever
    K251721 Xpert GI Panel
    K250218 Xpert® FII & FV
    K242071 Xpert Xpress CoV-2/Flu/RSV plus
    K231381 Xpert Xpress MVP; GeneXpert Xpress System
    K222638 Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
    K221160 Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
    K203429 Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
    K212213 Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
    K190076 Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
    Search all 50 clearances from Cepheid →