GL OB
AL &
RO UT
IN E
TE ST
S FI
BR IN
OL YS
IS TH
RO M
BO PH
IL IA
RE SE
AR CH
PR IM
AR Y
HE M
OS TA
SI S
CA LI
BR AT
OR S
& CO
NT RO
LS IN
DE X
M ON
IT OR
IN G
AN TI
CO AG
UL AN
T AU
XI LI
AR Y
RE AG
EN TS
BL EE
DI NG
DI
SO RD
ER S
27 26
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: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 32 tests
CE-IVD RK039A on- demand
Elisa Strips: 4 x 8 Sample Diluent-Anti-VIII: 2 x 12 mL Positive Control: 4 vials Negative Control: 4 vials Anti-IgG (Fcγ)-HRP immunoconjugate: 4 vials Conjugate Diluent: 1 x 10 mL Wash Solution: 2 x 12 mL 3,3', 5,5'-Tetramethylbenzidine: 1 x 10 mL 0.45 M Sulfuric acid: 1 x 3 mL
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
Research
ZYMUTEST™ Factor IX Measurement of FIX in human plasma, or in any biological medium where FIX is present, by Elisa.
COMPLETE SOLUTION Product Name RS Ref. Presentation ZYMUTEST™
Factor IX RUO RK032A 96 tests
(1) cf Dedicated intructions for use(1) cf Dedicated intructions for use