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    GeneProof MTHFR C677T PCR Kit

    CE IVD
    GeneProof MTHFR C677T 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 MTHFR C677T PCR Kit M677/025 real-time PCR 25 reactions
    GeneProof MTHFR C677T PCR Kit M677/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_M677_Instand_04_21_EN
    pdf, [915.1 kB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory Status CE IVD / EC Directive 98/79/EC
    Intended User For professional use in laboratories with trained staff
    Technology real-time PCR
    Type of Analysis qualitative
    Target Sequence C677T mutation in the gene for methylenetetrahydrofolate reductase (MTHFR)
    Analytical Sensitivity (LoD) Reaches up to 2 ng/µl
    Positive Percentage Agreement 100 % (CI95%: 78.12 % - 100 %)
    Negative Percentage Agreement 100 % (CI95%: 69.87 % - 100 %)
    Overall Percentage Agreement 100 % (CI95%: 85.87 % - 100 %)
    Validated Specimen whole blood
    Storage -20 ± 5 °C
    Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
    GeneProof PathogenFree DNA Isolation Kit
    Instruments

    croBEE Real-Time PCR System
    AMPLilab
    Applied Biosystems 7500 Real-Time PCR System
    AriaMx Real-Time PCR System
    CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
    LineGene 9600 Plus
    Rotor-Gene 3000/6000/Q*
    Required Detection Channels FAM, HEX
    External Quality Assessment Tested by Instand e.V. External Quality Assessment Panels - results at www.geneproof.com

    * In Rotor-Gene instruments leave all available detection channels on.

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_M677T_Advisory Notice _EN
    pdf, [543.68 kB]
    GP_M677_Instruction for Use_EN
    pdf, [248.96 kB]
    GP_M677_Instruction_for_Use_ES
    pdf, [286.05 kB]
    GP_M677_Instruction_for_Use_FR
    pdf, [258.33 kB]
    GP_M677_Instruction_for_Use_GR
    pdf, [298.45 kB]

    Declaration of Conformity

    GP_M677_Declaration of Conformity_EN
    pdf, [244.51 kB]

    MSDS

    GP_M677_Safety Data_Sheet_EN
    pdf, [399.19 kB]

    PCR Template

    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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    FAQ

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