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On this page you will find order codes, technical specifications and documents for the selected product.
|Product name||Catalog no.||Technology||Packaging|
|GeneProof Factor XIII V34L MC PCR Kit||FXIII/MC/200||PCR||for 180 tests|
|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|
myCROBE® Fully Automated Instrument
|Detection Channels||FAM, HEX|
|External Quality Assessment||Tested in Reference Institute for Bioanalytics Quality Assessment Panels - results at
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