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GeneProof Factor XIII V34L 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 XIII V34L MC PCR Kit FXIII/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 G103T Polymorphism of the gene F13A1 (V34L)
Specificity Single nucleotide guanine/thymine polymorphism in the gene F13A1 in site 103 (G103T)
Concentration Range 10-90 ng/µl
Negative Percentage Agreement 100 % (CI95%: 93,05 % - 100 %)
Positive Percentage Agreement 100 % (CI95%: 89,79 % - 100 %)
Overall Percentage Agreement 100 % (CI95%: 95,72 % - 100 %)
Validated Specimen Whole blood
Validated Extraction Methods myCROBE/croBEE 2.0 Universal Extraction Kit
Instruments

myCROBE® Fully Automated Instrument

Detection Channels FAM, HEX
External Quality Assessment Tested in Reference Institute for Bioanalytics Quality Assessment Panels - results at
www.geneproof.com

Documentation

Instruction for Use

GP_MC_FXIII_Instruction_for_Use_EN
pdf, [238.72 kB]

Declaration of Conformity

GP_MC_FXIII_Declaration_of_Conformity_EN
pdf, [595.12 kB]
Files are available only for registered users.

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