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GeneProof Factor II Prothrombin PCR Kit

CE IVD

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]
Choose all

EQA Panels

EQA results

; GP_FII_Instand_04_22_EN
pdf, [860.05 kB]
; GP_FII_Instand_04_21_EN
pdf, [915.1 kB]
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.

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