BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)

    K Number: K231758 · Decision Mar 11, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    24
    Applicant Total
    10
    Review Days
    269

    Basic Information

    Device Name
    NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
    K Number
    K231758
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3981
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Luminex Molecular Diagnostics, Inc.
    Date Received
    June 16, 2023
    Decision Date
    March 11, 2024
    Product Code
    QOF
    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
    QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

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    Other Clearances by Luminex Molecular Diagnostics, Inc.

    K Number Device Name
    K242613 NxTAG® Respiratory Pathogen Panel
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    K191160 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
    K183023 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
    K183030 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
    K170492 xTAG CYP2D6 Kit v3
    K163347 xTAG Cystic Fibrosis 39 Kit v2
    K163336 xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR