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510(k) Data Aggregation

    K Number
    K082150
    Device Name
    MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
    Manufacturer
    PREANALYTIX GMBH
    Date Cleared
    2009-02-04

    (189 days)

    Product Code
    NTW
    Regulation Number
    866.4070
    Why did this record match?
    Product Code :

    NTW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PAXgene™ Blood RNA System consists of a blood collection tube (PAXgene™ Blood RNA Tube) and nucleic acid purification kit (PAXgene™ Blood RNA Kit). It is intended for the collection, storage, and transport of blood and stabilization of intracellular RNA in a closed tube and subsequent isolation and purification of host RNA from whole blood for RT-PCR used in molecular diagnostic testing. Performance characteristics for the PAXgene™ Blood RNA System have only been established with "cfos and IL1B." The user is responsible for establishing appropriate PAXgene™ Blood RNA System performance characteristics for other target transcripts. PAXgene Blood RNA Kit is for the purification of intracellular RNA from whole blood collected in the PAXgene Blood RNA Tube. When the kit is used in conjunction with the PAXgene Blood RNA Tube, the system provides purified intracellular RNA from whole blood for RT-PCR used in molecular diagnostic testing. Performance characteristics for the PAXgene Blood RNA System have only been established with FOS and IL1B gene transcripts. The user is responsible for establishing appropriate PAXgene Blood RNA System performance characteristics for other target transcripts.
    Device Description
    The PAXgene™ Blood RNA System consists of: - PAXgene™ Blood RNA tubes - · PAXgene™ Blood RNA kit. The PAXgene™ Blood RNA tube is of a sterile, plastic, evacuated blood collection tube containing stabilization solution (tetradecyl trimethyl-ammonium oxalate and tartaric acid. These components serve to lyse cells, protect RNA molecules from degradation by ribonucleases (RNases) and prevent induction of gene expression. The kit consists of 5 aqueous buffer solutions for resuspending, binding, washing, and eluting RNA, RNase-free water, proteinase K. an RNase-Free DNase set, spin columns, microcentrifuge tubes, processing tubes, and secondary blood collection tube closures.
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    K Number
    DEN050003
    Device Name
    PAXGENE BLOOD RNA SYSTEM
    Manufacturer
    PREANALYTIX GMBH
    Date Cleared
    2005-04-18

    (49 days)

    Product Code
    NTW
    Regulation Number
    866.4070
    Why did this record match?
    Product Code :

    NTW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PAXgene™ Blood RNA System consists of a blood collection tube (PAXgene™ Blood RNA Tube) and nucleic acid purification kit (PAXgene™ Blood RNA Kit). It is intended for the collection, storage, and transport of blood and stabilization of intracellular RNA in a closed tube and subsequent isolation and purification of host RNA from whole blood for RT-PCR used in molecular diagnostic testing. Performance characteristics for the PAXgene™ Blood RNA System have only been established with "cfos and IL1B." The user is responsible for establishing appropriate PAXgene™ Blood RNA System performance characteristics for other target transcripts.
    Device Description
    The PAXgene™ Blood RNA System consists of: - the PAXgene™ Blood RNA tubes and . - the PAXgene™ Blood RNA kit. . The PAXgene™ Blood RNA tube is of a sterile, plastic, evacuated blood collection tube containing stabilization solution (tetradecyl trimethyl-ammonium oxalate and tartaric acid. These components serve to lyse cells, protect RNA molecules from degradation by ribonucleases (RNases) and prevent induction of gene expression. The kit consists of 5 aqueous buffer solutions for resuspending, binding, washing, and eluting RNA, RNase-free water, proteinase K, an RNase-Free DNase set, spin columns, microcentrifuge tubes, processing tubes, and secondary blood collection tube closures.
    Ask a Question

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