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510(k) Data Aggregation

    K Number
    DEN130042
    Device Name
    MISEQDX UNIVERSAL KIT 1.0
    Manufacturer
    ILLUMINA, INC.
    Date Cleared
    2013-11-19

    (46 days)

    Product Code
    PFT
    Regulation Number
    862.3800
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.
    Device Description
    The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx Platform. The MiSeqDx Universal Kit 1.0 consists of 5 boxes.
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