Spontaneous thromboembolic diseases are observed in presence of congenital or acquired deficiencies of antithrombin. These deficiencies are classified in 4 different groups:
   • Type I: Decreased AT concentration and decreased AT activity; this is the most frequent case.
   • Type II RS (Reactive Site): Normal AT concentration and decreased biological activity; a protein abnormality is present at the active site.
   • Type II HBS (Heparin Binding Site): Normal AT concentration, normal AT activity in the absence of heparin, but decreased in its presence.
   • Type II (Pleiotropic): Decreased AT concentration and activity; nonfunctional protein and at a lowered level.

* cf Dedicated instructions for use

• BIOPHEN™ AT anti-(h)-Xa LRT
  Liquid and Ready to use

  Determination of AT activity in human citrated plasma, using an anti-Xa chromogenic method (Human Xa).

  Reference	Registration	Presentation
  221123	CE-IVD	R1: 3 x 3 mL R2: 3 x 3 mL
  221127	CE-IVD	R1: 4 x 7.5 mL R2: 4 x 7.5 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• BIOPHEN™ AT LRT
  Liquid and Ready to use

  Determination of the heparin cofactor activity of AT in human citrated plasma, using an anti-Xa chromogenic method (Bovine Xa).

  Reference	Registration	Presentation
  221111	CE-IVD	R1: 4 x 11 mL R2 : 4 x 4 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• BIOPHEN™ Antithrombin

  Determination of AT activity in human citrated plasma, using an anti-Xa chromogenic method (Human Xa).

  Reference	Registration	Presentation
  221102	CE-IVD 510(k)	R1: 2 x 2.5 mL R2: 2 x 2.5 mL R3: 2 x 5 mL
  221105	CE-IVD 510(k)	R1: 4 x 5 mL R2: 4 x 5 mL R3: 4 x 10 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• BIOPHEN™ AT (Anti-IIa)

  Determination of AT activity, in presence of an excess of heparin, in human citrated plasma or purified milieu, using an anti-IIa chromogenic method (Bovine IIa).

  Reference	Registration	Presentation
  221122	CE-IVD	R1: 2 x 2.5 mL R2: 2 x 2.5 mL R3 : 2 x 25 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• LIAPHEN™ AT
  
  Liquid and Ready to use

  Determination of Antithrombin antigen (AT:Ag) in human citrated plasma using a latex turbidimetric assay.

  Reference	Registration	Presentation
  120002	CE-IVD	R1: 2 x 2 mL R2: 2 x 10 mL
  120008	CE-IVD	R1: 2 x 1.5 mL R2: 2 x 5 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

Assay of coagulation PC in plasma helps for the diagnosis of congenital or acquired PC deficiencies.
Acquired deficiencies are observed in hepatic diseases, during VKA therapy or in Disseminated Intravascular Coagulation (DIC).
Congenital deficiencies can be quantitative (Type I) or qualitative (Type II) and are associated with recurrent venous thromboses.
Congenital or acquired PC deficiency is a risk factor for venous thrombosis.

* cf Dedicated instructions for use

• HEMOCLOT™ Protein C

  Determination of PC in human citrated plasma with a clotting method.

  Reference	Registration	Presentation
  CK031K	CE-IVD	R1: 3 x 1 mL R2: 3 x 1 mL
  CK032K on-demand	CE-IVD	R1: 3 x 2 mL R2: 3 x 2 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• BIOPHEN™ Protein C LRT
  Liquid and Ready to use

  Determination of PC activity in human citrated plasma with a chromogenic assay, in liquid format.

  Reference	Registration	Presentation
  221211	CE-IVD	R1: 3 x 3 mL R2: 3 x 3 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• BIOPHEN™ Protein C 5

  Determination of PC activity in human citrated plasma with a chromogenic assay.

  Reference	Registration	Presentation
  221205	CE-IVD 510(k)	R1: 4 x 5 mL R2: 4 x 5 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ Protein C

  Determination of human PC antigen in human plasma by Elisa.

  Reference	Registration	Presentation
  RK027A	CE-IVD	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• Protein C Deficient Plasma
  

  Lyophilized, human citrated plasma, deficient for PC, for any protocol or research study where a source of human PC deficient plasma is required.

  Reference	Registration	Presentation
  DP100K on-demand	RUO	6 x 1 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• LIAPHEN™ Protein C
  Determination of Protein C antigen in human citrated plasma.

  Reference	Registration	Presentation
  120003	CE-IVD	R1: 4 x 5 mL R2: 4 x 2.3 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

Congenital or acquired PS deficiencies are associated with an increased risk of venous thromboembolism.
In the early stages of inflammatory diseases, free PS concentration is decreased because of an elevation of C4b-BP. PS may be decreased in various contexts such as dicoumarol or L-asparaginase therapy, in hepatic disorders, nephrotic syndrome, during pregnancy, related to oral contraceptives intake or œstrogen therapy, viral infections, DIC. Free PS may also be decreased in new-borns. PS is slightly lower in females than in males.
Inherited PS deficiencies are classified into three types:
   • Type I: decreased total and free PS levels (quantitative defects).
   • Type II: decreased PS activity but normal antigenic levels (rare qualitative defects).
   • Type III: normal levels of total PS but decreased free PS (free form distribution defect).

* cf Dedicated instructions for use

• LIAPHEN™ Free Protein S
  Liquid and Ready to use

  Determination of free PS Antigen (free PS:Ag) in human citrated plasma with a latex turbidimetric assay.

  Reference	Registration	Presentation
  120004	CE-IVD	R1: 4 x 3 mL R2: 4 x 4.4 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• HEMOCLOT™ Protein S

  Determination of PS activity in citrated human plasma with a clotting method.

  Reference	Registration	Presentation
  CK041K	CE-IVD	R1: 3 x 1 mL R2: 3 x 1 mL
  CK042K	CE-IVD	R1: 3 x 2 mL R2: 3 x 2 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ Free Protein S (II)

  Determination of Free PS (the activated Protein C (aPC) cofactor) in human plasma by Elisa.

  Reference	Registration	Presentation
  RK015B on-demand	CE-IVD	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE
• ZYMUTEST™ Total Protein S (II)

  Quantitative determination of Total Protein S in plasma, by Elisa. 

  Reference	Registration	Presentation
  RK021B	CE-IVD	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• Protein S Deficient Plasma
  

  Lyophilized, human citrated plasma, deficient for PS, for any protocol or research study where a source of human PS deficient plasma is required.

  Reference	Registration	Presentation
  DP110K	RUO	6 x 1 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

Factor V Leiden (FV-L) mutation is the most common hereditary thrombophilia risk factor. Patients carrying FV-L mutation have an increased risk of venous thrombosis.
This genetic anomaly can be evidenced with clotting assays, performed in presence or absence of APC.

* cf Dedicated instructions for use

• HEMOCLOT™ Quanti. VL

  Quantitative determination of FV-L, by measuring its resistance to the inactivation by APC, in the presence of PS, in human citrated plasma.

  Reference	Registration	Presentation
  CK065K	CE-IVD 510(k)	R1: 3 x 2 mL R2: 3 x 1 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

• ZYMUTEST™ Anti-Annexin V, IgG
  

  Measurement of autoantibodies to Annexin V of the IgG isotype, in human plasma.

  Reference	Registration	Presentation
  RK005A on-demand	RUO	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ Anti-Annexin V, IgM
  

  Measurement of autoantibodies to Annexin V of the IgM isotype, in human plasma.

  Reference	Registration	Presentation
  RK005B on-demand	RUO	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ Anti–PROTEIN S IgG–Isotype
  

  Measurement of autoantibodies to PS of the IgG isotype, in human plasma.

  Reference	Registration	Presentation
  RK020A on-demand	RUO	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ Anti–PROTEIN S IgM–Isotype
  

  Measurement of autoantibodies to PS of the IgM isotype, in human plasma.

  Reference	Registration	Presentation
  RK020B on-demand	RUO	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ Anti–PROTEIN Z IgG–Isotype
  

  Measurement of autoantibodies to Protein Z of the IgG isotype, in human plasma.

  Reference	Registration	Presentation
  RK025A on-demand	RUO	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ Anti–PROTEIN Z IgM–Isotype
  

  Measurement of autoantibodies to Protein Z of the IgM isotype, in human plasma.

  Reference	Registration	Presentation
  RK025B on-demand	RUO	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ Anti-Prothrombin IgG
  

  Measurement of autoantibodies to Prothrombin, of the IgG isotype, in human plasma.

  Reference	Registration	Presentation
  RK007A on-demand	RUO	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

• ZYMUTEST™ β2GPI
  

  Immuno-assay for measuring human Beta 2 Glyocoprotein I (β2GPI) in plasma, by Elisa.

  Reference	Registration	Presentation
  RK022A on-demand	RUO	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ Annexin V
  

  Measurement of human Annexin V in plasma, by Elisa.

  Reference	Registration	Presentation
  RK004A on-demand	RUO	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

• BIOPHEN™ Factor XIa
  

  Measurement of activated Factor XI (FXIa) activity, through FIX activation and Factor Xa generation.

  Reference	Registration	Presentation
  220412	RUO	R1A: 2 x 3 mL R1B: 2 x 3 mL R2: 2 x 3 mL R3: 2 x 3 mL R4: 2 x 25 mL Cal: 2 x 2 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

• BIOPHEN™ Factor IXa
  

  Determination of FIXa activity, in purified medium.

  Reference	Registration	Presentation
  221812	RUO	R1: 2 x 2.5 mL R2: 2 x 2.5 mL R3: 2 x 2.5 mL R4: 2 x 25 mL Cal: 2 x 1 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  

• HEMOCLOT™ Factor VIIa

  Determination of activated Factor VII (FVIIa) activity, in purified medium or citrated plasma.

  Reference	Registration	Presentation
  CK092K on-demand	CE-IVD	R1: 3 x 2 mL R2: 3 x 2 mL R3: 3 x 20 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• BIOPHEN™ Factor VIIa
  

  Determination of activated Factor VII (FVIIa) activity, in purified milieu.

  Reference	Registration	Presentation
  221312 on-demand	RUO	R1: 2 x 4 mL R2 : 2 x 2 mL R3 : 2 x 4 mL R4 : 2 x 25 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE