FXI deficiency is a very rare disease. It is an inherited genetic disorder, affecting both women and men. Bleeding has a variable expression in the affected kindreds, it is not always dependent on the residual FXI concentration.

• 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

  

Autosomal recessive inheritance.
FVII can be deficient in presence of vitamin K deficiency (hepatic diseases, primary biliary cirrhosis, deficiency in new-borns, antibiotherapy, …), vitamin K antagonists (dicoumarol therapy, ...), isolated deficiencies of FVII or accelerated clotting factor consumption (DIC).

• 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

  

No description for this category

• 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

  

Autosomal recessive inheritance.
FX deficiency is extremely rare.
People with mild FX deficiency experience easy bruising, nose or mouth bleeds, and bleeding after trauma or surgery. Symptoms for patients with severe FX deficiency include excessive umbilical cord bleeding, joint bleeds, intramuscular bleeds, and a high risk of intracranial hemorrhage in the first weeks of life.

• 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

  

Autosomal recessive inheritance.
Prothrombin deficiency is a rare hereditary coagulation disorder.
Symptoms include excessive umbilical cord bleeding, easy bruising, frequent nosebleeds and hemorrhaging after surgery or trauma. Women with FII deficiency experience menorrhagia, heavy menstrual bleeding, and postpartum hemorrhage after childbirth. Dysprothrombinemia results from a protein abnormality, which affects prothrombin clotting activity. Hypoprothrombinemia occurs when prothrombin concentration is decreased.

• 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

  

Autosomal recessive inheritance.
FV is deficient in presence of congenital or acquired FV deficiencies, hepatic disorders or accelerated clotting factor consumption (DIC).
High levels of FV are risk factors for venous thrombosis.

• 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

  

Autosomal recessive inheritance.
Umbilical cord bleeding is common in FXIII deficiency.
Some patients sustain a spontaneous intracranial hemorrhage, a brain bleed, which is the leading cause of mortality. Other symptoms of FXIII deficiency include bruising, nose and mouth bleeds, muscle bleeds and delayed bleeding after surgery.
Women can experience menorrhagia, long, heavy menstrual periods, and repeat miscarriages.
Men with FXIII deficiency may show signs of infertility.
Acquired FXIII deficiency can be observed in presence of autoantibodies.

• 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