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The device is a box containing lyophilized pooled plasmas from donors genotyped for the factor V Leiden mutation (FV : Q506) to be reconstituted with water by the user. Controls on the factor plasmas of either donors with helerazurous EV: O56 minuter by the user. Con plasmas of either donors with heterozygous FV:Q506 mutation or normal wild-type pattern. These controls are intended to be your for wolf These controls are intended to be used for quality assurance in connection with the IVD device 'Pefakit® APC-R Factor V Leiden'.

Pefakit® APC-R Factor V Leiden Controls is an in vitro diagnostic controls kit containing 3 vials each of the following 2 Ivophilized plasmas: C1: pooled human plasma from donors confirmed to be normal wild-type by FV Leiden PCR testing C2: pooled human plasma from donors confirmed to be heterozygous by FV Leiden PCR testing.

The device is a plasma based functional IVD assay for the decemination of resistance to activated protein C caused by the factor V Leiden mulation (EV-QEAC) vated protein C castin bascu for the december (FV: CS00) on automation of resistance to activated protein C caused by the factor V Leiden mulation (FV: (SOO) on automated a the super of of C backed by the factor v Leiden mulation (FV:Q506) on automated and

Pefakit® APC-R Factor V Leiden is an in vitro diagnostic test kit containing 3 vials each of the following 4 lyophilized reagents: R1: APC / RVV-V (+APC) Reagent (APC, RVV-V, Polybrene, Hepes, BSA) R2: APC / RVV-V (-APC) Reagent (RVV-V, Polybrene, Hepes, BSA) R3: PTA Reagent (Prothrombin Activator, EDTA, Hepes, BSA) R4: Dilution Plasma (Human Plasma, processed) For Quality Assurance/Quality Control the corresponding control kit 'Pefakit® APC-R Factor V Leiden Controls' has to be used. It contains 3 vials each of the following 2 lyophilized control plasmas: C1: pooled human plasma from donors confirmed to be normal wild-type by FV Leiden PCR testing C2: pooled human plasma from donors confirmed to be heterozygous by FV Leiden PCR testing