HEMOPHILIA A (1)

A Factor VIII (FVIII) (or antihemophilic Factor A) deficiency or dysfunction leads to hemophilia A, which is an hereditary or congenital hemorrhagic disease. Elevated concentrations of FVIII are observed in inflammatory or hepatic diseases and may be suggestive of an increased risk of venous thrombosis. The FVIII concentration is increased during pregnancy.

BIOPHEN™ FVIII Variant Determination of Factor VIII (FVIII) activity in human citrated plasma or FVIII concentrates. Design with FX from bovine origin thus in intensitive to Emicizumab.

REAGENT CALIBRATOR CONTROLS Product Name RS Ref. Presentation Product Name Ref. Product Name Ref.

BIOPHEN™ FVIII Variant CE-IVD 227102

R1: 2 x 2.5 mL BIOPHEN™

Plasma Calibrator

222101

BIOPHEN™ Normal Control Plasma

BIOPHEN™ Abnormal Control Plasma

223201

223301 R2: 2 x 2.5 mL

R3: 2 x 2.5 mL

R4: 4 x 20 mL

BIOPHEN™ FVIII:C Determination of Factor VIII activity (FVIII:C) in citrated human plasma or therapeutic concentrates.

REAGENT CALIBRATOR CONTROLS Product Name RS Ref. Presentation Product Name Ref. Product Name Ref.

BIOPHEN™ FVIII:C CE-IVD

221402

R1: 2 x 2.5 mL

BIOPHEN™ Plasma Calibrator

222101

BIOPHEN™ Normal Control Plasma

BIOPHEN™ Abnormal Control Plasma

223201

223301

R2: 2 x 2.5 mL R3: 2 x 2.5 mL R4: 4 x 25 mL

221406

R1: 2 x 6 mL R2: 2 x 6 mL R3: 2 x 6 mL R4: 4 x 25 mL

Factor VIII:C Deficient Plasma Used in combination with the CEPHEN™ (ref. CK511K CK512K CK515K CK515L) to measure Factor VIII:C clotting activity in human citrated plasma, in the presence of cephalin, activator (aPTT reagent) and calcium.

REAGENT CALIBRATOR CONTROLS Product Name RS Ref. Presentation Product Name Ref. Product Name Ref.

Factor VIII:C Deficient Plasma

CE-IVD DP040A 1 x 1 mL BIOPHEN™

Plasma Calibrator

222101

BIOPHEN™ Normal Control Plasma

BIOPHEN™ Abnormal Control Plasma

223201

223301DP040K 6 x 1 mL

DIAGNOSTIC OF INHIBITORS

ZYMUTEST™ Anti-VIII MonoStrip IgG Measurement of auto and allo-antibodies to FVIII, of the IgG isotype, in human plasma.

COMPLETE SOLUTION Product Name RS Ref. Presentation ZYMUTEST™

Anti-VIII MonoStrip IgG

CE-IVD RK039A on- demand

32 tests

HEMOPHILIA B (1)

A Factor IX (FIX) (or antihemophilic Factor B) deficiency or dysfunction leads to the hemophilia B disease, an hereditary or congenital coagulation disorder. FIX levels are reduced in patients receiving anti-vitamin K treatment, or in diseases such as liver disorders, cirrhosis or DIC. High FIX concentrations may be suggestive of an increased risk of venous thrombosis.

BIOPHEN™ FIX Determination of FIX activity in citrated human plasma or therapeutic concentrates.

REAGENT CALIBRATOR CONTROLS Product Name RS Ref. Presentation Product Name Ref. Product Name Ref.

BIOPHEN™ FIX CE-IVD

221801

R1: 2 x 1 mL

BIOPHEN™ Plasma Calibrator

222101

BIOPHEN™ Normal Control Plasma

BIOPHEN™ Abnormal Control Plasma

223201

223301

R2: 2 x 1 mL R3: 2 x 1 mL R4: 2 x 15 mL

221802

R1: 2 x 2.5 mL R2: 2 x 2.5 mL R3: 2 x 2.5 mL R4: 2 x 25 mL

221806

R1: 2 x 6 mL R2: 2 x 6 mL R3: 2 x 6 mL R4: 4 x 25 mL

Factor IX Deficient Plasma Used in combination with CEPHEN™ (ref. CK511K CK512K CK515K CK515L) to measure FIX clotting activity in human citrated plasma, in the presence of cephalin, activator (aPTT reagent) and calcium.

REAGENT CALIBRATOR CONTROLS

Product Name RS Ref. Presentation Product Name Ref. Product Name Ref.

Factor IX Deficient Plasma

CE-IVD DP050A 1 x 1 mL BIOPHEN™

Plasma Calibrator

222101

BIOPHEN™ Normal Control Plasma

BIOPHEN™ Abnormal Control Plasma

223201

223301 DP050K 6 x 1 mL

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