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|Product name||Catalog no.||Technology||Packaging|
|GeneProof Factor V Leiden PCR Kit||FV/025||real-time PCR||25 reactions|
|GeneProof Factor V Leiden PCR Kit||FV/100||real-time PCR||100 reactions|
|Indication||in vitro diagnostic medical device|
|Intended User||For professional use in laboratories with trained staff|
|Type of Analysis||qualitative|
|Target Sequence||G1691A polymorphism of factor V Leiden|
|Diagnostic Specificity||100 %|
|Diagnostic Sensitivity||100 %|
|Validated Specimen||whole blood|
|Storage||-20 ± 5 °C|
|Validated Extraction Methods||croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit
croBEE Real-Time PCR System*
|Required Detection Channels||FAM, HEX|
|External Quality Assessment||regularly tested by Instand e.V. External Quality Assessment Panels - results at www.geneproof.com|
* Validated instruments
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GeneProof merges with American Laboratory Products Company.