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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% 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 to which an exogenous source of human von Willebrand Factor (vWF) has been added and buffered with HEPES. Factor VIII has been assayed at less than 1% of normal activity levels and vWF antigen and activity are >50%. It will be provided to users frozen in small-volume aliquots (25 vials of 1.0 mL, and 25 vials of 1.5 mL). Vials will be packaged into boxes; these will be frozen during the manufacturing process and will be shipped and stored frozen until use to preserve the integrity of the components

CRYOcheck Chromogenic Factor IX is for clinical laboratory use in the quantitative determination of factor IX activity in 3.2% citrated human plasma. It is intended to be used in identifying factor IX deficiency and as an aid in the management of hemophilia B in individuals aged 2 years and older. For in vitro diagnostic use.

CRYOcheck Chromogenic Factor IX is used for determination of FIX activity and contains the following four components, packaged in vials, and provided frozen to preserve the integrity of the components: Reagent 1: Human FVIII, human FX, bovine FV and a fibrin polymerization inhibitor. Reagent 2: Human FXIa, human FII, calcium chloride and phospholipids Reagent 3: FXa Substrate containing EDTA and a thrombin inhibitor. Diluent Buffer: Tris buffer solution containing 1% BSA and a heparin antagonist.

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.

CRYOcheck Hex LA is comprised of three reagents supplied in a frozen format as follows: LA Start: Pooled normal plasma with buffer and a heparin neutralizer. LA Correct: Pooled normal plasma with buffer, a heparin neutralizer, and inverted hexagonal phase phospholipid. LA APTT: Silica-based lupus sensitive APTT reagent with stabilizer.

CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. 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 Chromogenic Factor VIII is used for determination of FVIII activity and contains the following four components, packaged in glass vials and provided frozen to preserve the integrity of the components: Reagent 1: Bovine FX and a fibrin polymerization inhibitor, with activators and stabilizers. Reagent 2: Human FIIa, human FIXa, calcium chloride and phospholipids. Reagent 3: FXa substrate containing EDTA and a thrombin inhibitor. Diluent Buffer: Tris buffer solution containing 1% BSA and a heparin antagonist.

The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a Factor VIII activity assay to enable the performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years or older. For in vitro diagnostic use.

The FVIII Inhibitor Kit is used in the CDC modification of the Nijmegen-Bethesda assay and contains the following components: Imidazole Buffered Pooled Normal Plasma (IB-PNP): Pooled normal plasma from a minimum of twenty donors with a factor VIII activity value of 95-113% and buffered with imidazole to a pH of 7.3 – 7.5. Imidazole Buffered Bovine Serum Albumin (IB-BSA): A 4% BSA solution buffered with imidazole to a pH of 7.3-7.5. Negative Factor VIII Inhibitor Control: Pooled normal plasma from a minimum of five donors buffered with HERES to a pH of 6.2-8.2 Positive Factor VIII Inhibitor Control: HEPES buffered (pH 6.2-8.2) immunodepleted FVIII deficient plasma to which anti-human FVIII antibodies have been added.

cryocheck Clot APCR is a clotting assay intended to screen for resistance to activated protein C in citrated human plasma from individuals with the factor V Leiden mutation.

cryocheck Clot APCR consists of: - 5 x 2.0 mL Activator Reagent (APC-AR) . - 5 x 4.0 mL Russell's Viper Venom Reagent (APC-RV)

cryocheck™ Clot S™ is a clot-based assay intended for the quantitative determination of protein S activity in citrated human plasma. cryocheck™ Clot S™ is used to diagnose protein S deficiency (congenital or acquired) which is indicative of an increased risk of thromboembolism. A deficiency in protein S may produce recurrent thrombotic episodes. Congenital deficiencies of protein S are classified as three types: - type I deficiencies correspond to reduced antigen levels of both total and free protein S . - type II deficiencies are characterized by a reduced protein S activity but with normal . antigen levels of both total and free protein S - type III deficiencies are defined by a reduced antigen level and activity of free protein S . but the antigen level of total protein S remains normal Acquired protein S deficiencies are associated with several clinical states: - oral anticoagulant therapy ● - liver disease . - disseminated intravascular coagulation . - . oral contraceptives - oestrogen therapy . - acute phase inflammatory responses . - pregnancy . - newborns

CRYOcheck™ Clot S™ consists of: • Protein S Deficient Plasma - contains citrated pooled normal human plasma that has been depleted of protein S by immunoadsorption, buffers and stabilizers. • Clot S Activator - contains activated protein C, Russell's viper venom, heparin neutralizing agents, buffers and stabilizers. • Precision BioLogic Clot C & S Diluent (available separately from Precision BioLogic).

CryoCheck Clot C is a clot-based assay intended for the quantitative determination of protein C activity in citrated human plasma.

CryoCheck Clot C consists of: Protein C Deficient Plasma - contains citrated pooled normal human plasma that has been depleted of protein C by immunoadsorption. Clot C Activator - Contains protein isolated from the venom of Agkistrodon contortrix capable of activating protein C in human plasma, Russell's viper venom, phospholipids, heparin neutralizing agents, buffers and stabilizers. CS Diluent (provided separately by Precision BioLogic).

CryoCheck Weak Lupus Positive Control is prepared from human source plasma and is recommended for use as a positive control in assays for lupus anticoagulant.

CryoCheck Weak Lupus Positive Control contains citrated human plasma collected from donors that have tested positive in accordance with the revised criteria of the SSC Subcommittee for the Standardization of Lupus Anticoagulants. Source plasmas are processed in a manner that yields platelet-poor plasmas. Plasma is then buffered, aliquoted and rapidly frozen.

ChromoCheck™ Antithrombin is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.

ChromoCheck™ Antithrombin is a chromogenic assay consisting of a synthetic substrate, Factor Xa, and a Tris Heparin Buffer