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    GeneProof Factor V Leiden PCR Kit

    CE IVD
    GeneProof Factor V Leiden PCR Kit

    PRODUCT ADVANTAGES

     

    SINGLE TUBE READY-TO-USE MASTER MIX

    • Contains all components for PCR amplification
    • Reduces the need of qualified laboratory staff
    • Enables quick and reliable results


    UNIVERSAL PCR PROFILE

    • Uniform reaction format
    • All PCR Kits from the group Thrombotic Mutations are easily combinable with each other
    • Simplifies laboratory workflow

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof Factor V Leiden PCR Kit FV/025 real-time PCR 25 reactions
    GeneProof Factor V Leiden PCR Kit FV/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_FV_Instand_04_21_EN
    pdf, [915.1 kB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Intended User For professional use in laboratories with trained staff
    Technology real-time PCR
    Type of Analysis qualitative
    Target Sequence G1691A polymorphism of factor V Leiden
    Diagnostic Specificity 100 %
    Diagnostic Sensitivity 100 %
    Validated Specimen whole blood
    Storage -20 ± 5 °C
    Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
    GeneProof PathogenFree DNA Isolation Kit
    Instruments

    croBEE Real-Time PCR System*
    Applied Biosystems 7500 Real-Time PCR System
    AriaMx Real-Time PCR System
    LightCycler® 2.0 / 480
    CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
    LineGene 9600 Plus
    Rotor-Gene 3000/6000/Q
    SLAN® Real-Time PCR System
    QuantStudio™ 3 / 5 Real-Time PCR System
    StepOne™ / StepOnePlus™ Real-Time PCR System
    Mic qPCR Cycler
    Required Detection Channels FAM, HEX
    External Quality Assessment regularly tested by Instand e.V. External Quality Assessment Panels - results at www.geneproof.com
    Certification CE IVD

    * Validated instruments

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_Advisory Notice_EN
    pdf, [177.45 kB]
    GP_FV_Instruction for Use_EN
    pdf, [896.72 kB]
    GP_FV_Instruction for Use_ES
    pdf, [109.58 kB]
    GP_FV_Instruction for Use_GR
    pdf, [690.23 kB]
    GP_FV_Manual de Uso_SP
    pdf, [109.58 kB]

    Declaration of Conformity

    GP_FV_Declaration of Conformity_EN
    pdf, [247.67 kB]

    MSDS

    GP_FV_Safety_Data_Sheet_EN
    pdf, [274.51 kB]

    PCR Template

    GP_FV_Mic
    micassay, [11.39 kB]
    GP_Genetics_ABI7500
    edt, [11.02 kB]
    GP_Genetics_AriaMX
    amxt, [3.57 kB]
    GP_Genetics_BioRad
    prcl, [1.32 kB]
    GP_Genetics_CroBee
    fqt, [4.85 kB]
    GP_Genetics_QS3
    edt, [7.97 kB]
    GP_Genetics_QS5
    edt, [8.02 kB]
    RG_Genetics
    ret, [13.39 kB]

    Product Leaflet

    GP_Thrombotic_Mutations_Leaflet_EN
    pdf, [129.06 kB]

    Manual

    Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
    pdf, [1.43 MB]
    croBEE Real-Time PCR System_EN
    pdf, [5.9 MB]
    LightCycler 2.0_EN
    pdf, [1.96 MB]
    LightCycler 480/Instrument II_EN
    pdf, [2.03 MB]
    Mic qPCR Cycler_EN
    pdf, [2.33 MB]
    QuantStudio 3/5 Real-Time PCR System_EN
    pdf, [1.81 MB]
    Rotor-Gene_3000_6000_Q_EN
    pdf, [2.22 MB]
    Files are available only for registered users.

    Order

    +420 543 211 679
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    Technical Support 

    Send request
    +420 730 176 222
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