No description for this category

• ZYMUTEST™ Anti-VIII MonoStrip IgG

  Measurement of auto and allo-antibodies to FVIII, of the IgG isotype, in human plasma.

  Reference	Registration	Presentation
  RK039A on-demand	CE-IVD	32 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

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.

 

* cf Dedicated instructions for use

• BIOPHEN™ FIX

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

  Reference	Registration	Presentation
  221801	CE-IVD	R1: 2 x 1 mL R2: 2 x 1 mL R3: 2 x 1 mL R4: 2 x 15 mL
  221802	CE-IVD	R1: 2 x 2.5 mL R2: 2 x 2.5 mL R3: 2 x 2.5 mL R4: 2 x 25 mL
  221806	CE-IVD	R1: 2 x 6 mL R2: 2 x 6 mL R3: 2 x 6 mL R4: 4 x 25 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• 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.

  Reference	Registration	Presentation
  DP050A	CE-IVD	1 x 1 mL
  DP050K	CE-IVD	6 x 1 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ Factor IX
  

  Measurement of FIX in human plasma, or in any biological medium where FIX is present, by Elisa.

  Reference	Registration	Presentation
  RK032A	RUO	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

Willebrand's disease is the most common bleeding disorder. It concerns a group of various types of von Willebrand disease. vWF functional or quantitative deficiency allows characterizing von Willebrand disease, which can be classed into 3 types:
   • Type 1: vWD is characterized by a partial quantitative deficit of vWF (most frequently).
   • Type 2: vWD is characterized by an abnormal vWF adhesion activity. It is divided into 4 subtypes: 2A, 2B, 2M and 2N, depending on the multimers functional abnormality.
   •Type 3: vWD is characterized by a severe quantitative vWF deficiency.

vWF deficiencies can be associated with various other pathologies, thus constituting an acquired von Willebrand disease. When vascular endothelium is affected, the vWF concentration can be increased in relation to inflammatory processes.

 

* www.hemophilia.org

• LIAPHEN™ vWF:Ag
  Liquid and Ready to use

  Measurement of von Willebrand Factor Antigen (vWF: Ag), in human citrated plasma, with a latex turbidimetric assay.

  Reference	Registration	Presentation
  120206	CE-IVD	R1: 4 x 5 mL R2: 4 x 6 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ vWF

  Measurement of von Willebrand Factor (vWF) in human plasma, by Elisa.

  Reference	Registration	Presentation
  RK030A	CE-IVD	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ vWF:CBA

  Measurement of human von Willebrand Factor (vWF) Collagen Binding Activity (CBA) in human activated plasma.

  Reference	Registration	Presentation
  RK038A	CE-IVD	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• vWF Deficient Plasma
  

  For any study or research protocol where a source of human vWF deficient plasma is required.

  Reference	Registration	Presentation
  DP150K	RUO	6 x 1 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

No description for this category

• Factor XII Deficient Plasma

  Used in combination with CEPHEN™ (ref. CK511K – CK512K – CK515K – CK515L) to measure FXII clotting activity in human citrated plasma.

  Reference	Registration	Presentation
  DP080A	CE-IVD	1 x 1 mL
  DP080K	CE-IVD	6 x 1 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

• Factor XI Deficient Plasma

  Used in combination with CEPHEN™ (ref. CK511K – CK512K – CK515K – CK515L) to measure FXI clotting activity in human citrated plasma.

  Reference	Registration	Presentation
  DP070A	CE-IVD	1 x 1 mL
  DP070K	CE-IVD	6 x 1 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

• Factor VII Deficient Plasma

  Used in combination with PT-Phen™ (ref. CK581 - CK582 - CK583 - CK584K - CK584L - CK586K - CK586L) to measure FVII clotting activity in human citrated plasma.

  Reference	Registration	Presentation
  DP030A	CE-IVD	1 x 1 mL
  DP030K	CE-IVD	6 x 1 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• BIOPHEN™ FVII
  

  Determination of FVII chromogenic activity in purified medium or citrated plasma.

  Reference	Registration	Presentation
  221304	RUO	R1: 2 x 4 mL R2: 2 x 2 mL R3: 2 x 4 mL R4: 4 x 25 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ Factor VII
  

  Measurement of FVII antigen in human plasma, or in any biological medium where FVII can be present, by Elisa.

  Reference	Registration	Presentation
  RK036A	RUO	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

• HEMOCLOT™ VII+X

  Used in combination with PT-Phen™ (ref. CK581 - CK582 - CK583 - CK584K - CK584L - CK586K - CK586L) to measure FVII+FX clotting activity in human citrated plasma.

  Reference	Registration	Presentation
  CK051K	CE-IVD	6 x 1 mL
  CK051L	CE-IVD	20 x 1 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

• Factor X Deficient Plasma

  Used in combination with PT-Phen™ (ref. CK581 - CK582 - CK583 - CK584K - CK584L - CK586K - CK586L) to measure FX clotting activity in human citrated plasma.

  Reference	Registration	Presentation
  DP060A	CE-IVD	1 x 1 mL
  DP060K	CE-IVD	6 x 1 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• BIOPHEN™ Factor X
  

  Determination of FX chromogenic activity in citrated human plasma.

  Reference	Registration	Presentation
  221705	RUO	R1: 4 x 2.5 mL R2: 4 x 2.5 mL R3: 4 x 5 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ Factor X
  

  Measurement of human FX antigen in human plasma, or in any biological medium where FX is present, by Elisa.

  Reference	Registration	Presentation
  RK033A	RUO	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

• Factor II Deficient Plasma

  Used in combination with PT-Phen™ (ref. CK581 - CK582 - CK583 - CK584K - CK584L - CK586K - CK586L) to measure FII or Prothrombin activity in human citrated plasma.

  Reference	Registration	Presentation
  DP010A	CE-IVD	1 x 1 mL
  DP010K	CE-IVD	6 x 1 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

• Factor V Deficient Plasma

  Used in combination with PT-Phen™ (ref. CK581 - CK582 - CK583 - CK584K - CK584L - CK586K - CK586L) to measure FV or Proaccelerin activity in human citrated plasma.

  Reference	Registration	Presentation
  DP020A	CE-IVD	1 x 1 mL
  DP020K	CE-IVD	6 x 1 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ Factor V
  

  Measurement of human FV antigen in plasma, or in any fluid where Factor V can be present, by Elisa.

  Reference	Registration	Presentation
  RK009A on-demand	RUO	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

• BIOPHEN™ Factor XIII

  Determination of FXIII activity in human citrated plasma.
  Reagent and material required: automatic instrument for chromogenic assays with a wavelength at 340 nm.

  Reference	Registration	Presentation
  227005	CE-IVD	R1: 3 x 4 mL R2: 3 x 5 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• Factor XIII Deficient Plasma
  

  For any study or research protocol where a source of human FXIII deficient plasma is required.

  Reference	Registration	Presentation
  DP200K	RUO	6 x 1 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ Factor XIII-A
  

  Measurement of FXIII (subunit A) in human plasma, or in any biological medium where Factor XIII (FXIII) is present, by Elisa.

  Reference	Registration	Presentation
  RK034A on-demand	RUO	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE