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GeneProof PAI-1 Genotyping 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 PAI-1 Genotyping MC PCR Kit PAI1/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 Polymorphism in SERPINE1 gene for Plasminogen activator inhibitor 1 (PAI-1) (rs1799762)
Specificity Insertion-deletion polymorphism of guanosine 4G/5G at site -675 in the promoter of SERPINE1
gene for PAI-1 (rs1799762)
Concentration Range 10-90 ng/µl
Negative Percentage Agreement 100 % (CI95%: 83,42 % - 100 %)
Positive Percentage Agreement 100 % (CI95%: 94,84 % - 100 %)
Overall Percentage Agreement 100 % (CI95%: 95,94 % - 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_PAI1_Advisory Notice_EN
pdf, [385.08 kB]
; GP_MC_PAI1_Instruction_for_Use_EN
pdf, [142.88 kB]

Declaration of Conformity

; GP_MC_PAI1_Declaration_of_Conformity_EN
pdf, [599.57 kB]


; GP_MC_PAI1_Safety_Data_Sheet_EN
pdf, [273.81 kB]
Files are available only for registered users.


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