Thrombophilia and coagulation inhibitor IVDs

Intended purpose

The product Coagulation ELITe MGB® Kit is an in vitro diagnostic medical device intended to be used as qualitative nucleic acids RealTime PCR assay for the allelic discrimination of the following three loci in human genomic DNA samples extracted from clinical specimens: - coagulation Factor V gene, single nucleotide polymorphism (SNP) G1691A (Leiden), - coagulation Factor II gene, SNP G20210A, - 5,10-methylenetetrahydrofolate reductase (MTHFR) gene, SNP C677T. The product is intended for use as an aid in assessing the risk of deep vein thrombosis in patients suspected of having coagulation disorders and at risk of deep vein thrombosis.