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GeneProof Factor II Prothrombin MC PCR Kit

CE IVD myCROBE® line

On this page you will find order codestechnical specifications and documents for the selected product.

Order information

Product name Catalog no. Technology Packaging
GeneProof Factor II Prothrombin MC PCR Kit FII/MC/200 PCR for 180 tests

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
Test Principle Real-time polymerase chain reaction (PCR)
Type of Analysis Qualitative
Automated / Manual detection Automated
Target G20210A Polymorphism in the F2 gene of Factor II Prothrombin (rs1799963)
Specificity Single nucleotide guanine/adenine polymorphism in the F2 gene of Factor II Prothrombin at site 20210 (rs1799963)
Concentration Range 10-90 ng/µl
Negative Percentage Agreement 100 % (CI95%: 62.88 % - 100 %)
Positive Percentage Agreement 100 % (CI95%: 97.31 % - 100 %)
Overall Percentage Agreement 100 % (CI95%: 97.44 % - 100 %)
Validated Specimen Whole blood
Validated Extraction Methods myCROBE/croBEE 2.0 Universal Extraction Kit

myCROBE® Fully Automated Instrument

Detection Channels FAM, HEX
External Quality Assessment Regularly tested in INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com

Instructions for Use

; GP_MC_FII_Advisory_Notice_EN
pdf, [544.26 kB]
; GP_MC_FII_Instruction_for_Use_EN
pdf, [147.35 kB]

Declaration of Conformity

; GP_MC_FII_Declaration_of_Conformity_EN
pdf, [598.5 kB]


; GP_MC_FII_Safety_Data_Sheet_EN
pdf, [273.77 kB]
Files are available only for registered users.


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