BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇨🇦 Canada

    XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)

    K Number: DEN130003 · Decision Jan 14, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    37
    Applicant Total
    26
    Review Days
    3

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    Basic Information

    Device Name
    XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)
    K Number
    DEN130003
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    866.3990
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Luminex Molecular Diagnostics, Inc.
    Date Received
    January 11, 2013
    Decision Date
    January 14, 2013
    Product Code
    PCH
    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
    PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

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    Other Clearances by Luminex Molecular Diagnostics, Inc.

    K Number Device Name
    K242613 NxTAG® Respiratory Pathogen Panel
    K231758 NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
    K193167 NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
    K191161 xTAG Gastrointestinal Pathogen Panel (GPP)
    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
    K163336 xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
    K163347 xTAG Cystic Fibrosis 39 Kit v2
    Search all 26 clearances from Luminex Molecular Diagnostics, Inc. →