Category: US FDA 510

Factor II

INFINITI System Assay for Factor II (IVD) The INFINITI System Assay for Factor II is FDA 510(k) cleared as an in vitro diagnostic assay (IVD). The INFINITI System Assay for Factor II is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The INFINITI System Assay for Factor II utilizes the […]

Factor V Leiden

INFINITI System Assay for Factor V Leiden (IVD) The INFINITI System Assay for Factor V is FDA 510(k) cleared as an in vitro diagnostic assay (IVD). The INFINITI System Assay for Factor V is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The INFINITI System Assay for Factor V utilizes the Factor V Intellipac, Factor V […]

Factor II-V Leiden

NFINITI System Assay for Factor II-V Leiden (IVD) The INFINITI System Assay for Factor II-V is FDA 510(k) cleared as an in vitro diagnostic assay (IVD). The INFINITI System Assay for Factor II-V is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The INFINITI System Assay for Factor II-V utilizes the Factor II […]

Warfarin Assay

INFINITI Warfarin Assay (IVD) The INFINITI Warfarin Assay is FDA 510(k) cleared as an in vitro diagnostic assay (IVD). The INFINITI Warfarin Assay is indicated for use to identify individuals at risk for sensitivity to Warfarin. The INFINITI Warfarin Assay utilizes the Warfarin Assay Intellipac, Warfarin Assay Amp Mix and Warfarin Assay BioFlimChip Microarray. The INFINITI Warfarin […]

CYP2C19 Assay

INFINITI CYP2C19 Assay The INFINITI CYP2C19 Assay is FDA 510(k) cleared as an in vitro diagnostic assay (IVD).  The INFINITI CYP2C19 Assay is indicated for use as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP450 2C19 gene product. The INFINITI CYP2C19 Assay is not indicated to be used to […]