CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative determination of Factor VIII activity in 3.2% sodium citrated human plasma based on the activated partial thromboplastin time (APTT) assay. It is intended to be used in identifying Factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use. CRYOcheck Factor VIII Deficient Plasma with VWF is normal human citrated plasma which has been immunodepleted of factor VIII and which contains normal levels of von Willebrand Factor (VWF), buffered with HEPES. Factor VIII has been assayed at less than 1% of normal antigen and activity levels while VWF antigen and activity levels are >50%. Device is provided frozen as 25 vials of 1.0 mL

CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative determination of Factor VIII activity in 3.2% sodium citrated human plasma based on the activated partial thromboplastin time (APTT) assay. It is intended to be used in identifying Factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use. CRYOcheck Factor VIII Deficient Plasma with VWF is normal human citrated plasma which has been immunodepleted of factor VIII and which contains normal levels of von Willebrand Factor (VWF), buffered with HEPES. Factor VIII has been assayed at less than 1% of normal antigen and activity levels while VWF antigen and activity levels are >50%. Device is provided frozen as 25 vials of 1.0 mL

CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.