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    GeneProof Factor II Prothrombin PCR Kit

    CE IVD
    GeneProof Factor II Prothrombin PCR Kit

    PRODUCT ADVANTAGES

     

    EASY-TO-USE CONCEPT

    • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
    • No additional PCR reagents pipetting necessary

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other GeneProof PCR kits in one 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 II Prothrombin PCR Kit FII/025 real-time PCR 25 reactions
    GeneProof Factor II Prothrombin PCR Kit FII/100 real-time PCR 100 reactions

    Product Leaflet

    Product Leaflet

    ; GP_THROMB_Leaflet_EN
    pdf, [134.34 kB]
    open
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    EQA Panels

    EQA results

    ; GP_FII_Instand_04_22_EN
    pdf, [860.05 kB]
    open
    ; GP_FII_Instand_04_21_EN
    pdf, [915.1 kB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory Status CE IVD
    Intended User For professional use in laboratories with trained staff
    Technology Real-time PCR
    Type of Analysis Qualitative
    Target Sequence G20210A polymorphism in F2 gene for Factor II Prothrombin (rs1799963)
    Analytical Sensitivity (LoD) reaches up to 2 ng/μl
    Negative Percentage Agreement  100 % (CI95%: 93.05 % - 100 %)
    Positive Percentage Agreement  100 % (CI95%: 82.83 % - 100 %)
    Overall Percentage Agreement  100 % (CI95%: 94.84 % - 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
    Applied Biosystems 7300 / 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
    Mic qPCR Cycler
    QuantStudio™ 3 / 5 Real-Time PCR System
    Rotor-Gene 3000/6000/Q*
    SLAN® Real-Time PCR System
    StepOne™ / StepOnePlus™ Real-Time PCR System
    Required Detection Channels FAM, HEX/JOE/VIC
    External Quality Assessment Regularly tested in Instand e.V. External Quality Assessment Panels - results at www.geneproof.com

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

    Instructions for Use

    ; Declaration of Verification of the kits with medical devices
    pdf, [1.61 MB]
    ; GP_FII_Advisory Notice_03_2023_EN
    pdf, [521.82 kB]
    ; GP_FII_Advisory_Notice_11_22_EN
    pdf, [504.15 kB]
    ; GP_FII_Instructions_for_Use_DE
    pdf, [142.48 kB]
    ; GP_FII_Instructions_for_Use_EL
    pdf, [195.64 kB]
    ; GP_FII_Instructions_for_Use_ES
    pdf, [137.77 kB]
    ; GP_FII_Instructions_for_Use_IT
    pdf, [142.89 kB]
    ; GP_FII_Instruction_for_Use_EN
    pdf, [140.57 kB]

    Declaration of Conformity

    ; GP_FII_Declaration_of_Conformity_EN
    pdf, [568.88 kB]

    MSDS

    ; GP FII_Safety_Data_Sheet_IT
    pdf, [275.63 kB]
    ; GP_FII_Safety_Data_Sheet_EN
    pdf, [274.54 kB]

    PCR Template

    ; GP_FII_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]

    Manual

    ; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
    pdf, [1.43 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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    Customer Support 

    Send request
    +420 730 176 222
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