No description for this category

• HEMOCLOT™ Thrombin Inhibitors

  Anti-IIa method for the measurement of Dabigatran and other Direct Thrombin Inhibitors (DTIs), on human citrated plasma. This method is also appropriate for testing Argatroban or Bivalirudin in plasma.

  Reference	Registration	Presentation
  CK002K	CE-IVD	R1: 3 x 1 mL R2: 3 x 1 mL
  CK002L	CE-IVD	R1: 3 x 2.5 mL R2: 3 x 2.5 mL

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• BIOPHEN™ DTI

  Anti-IIa chromogenic method for the determination of Direct Thrombin (FIIa) Inhibitors (DTI) such as Dabigatran and Bivalirudin, in citrated human plasma.

  Reference	Registration	Presentation
  220202	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

  

Measurement of heparin dependent antibodies.

• ZYMUTEST™ HIA IgG

  Detection of heparin-dependent antibodies (anti heparin PF4 complexes) of the IgG isotype, responsible of heparin induced thrombocytopenia (HIT) in human plasma or serum or any other biological fluids where these antibodies must be detected.

  Reference	Registration	Presentation
  RK040A	CE-IVD 510(k)	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ HIA IgM

  Detection of heparin-dependent antibodies (anti heparin PF4 complexes) of the IgM isotype, responsible of heparin induced thrombocytopenia (HIT) in human plasma or serum or any other biological fluids where these antibodies must be detected.

  Reference	Registration	Presentation
  RK040B on-demand	CE-IVD	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE
• ZYMUTEST™ HIA IgA

  Detection of heparin-dependent antibodies of the IgA isotype (anti heparin PF4 complexes), responsible of heparin induced thrombocytopenia (HIT) in human plasma or serum or any other biological fluids where these antibodies must be detected.

  Reference	Registration	Presentation
  RK040C on-demand	CE-IVD	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE
• ZYMUTEST™ HIA IgGAM

  Detection and qualitative screening assay of heparin-dependent antibodies (anti heparin PF4 complexes), responsible of heparin induced thrombocytopenia (HIT) whatever the isotype is: IgG, IgA and IgM, in human plasma or serum or any other biological fluids where these antibodies must be detected.

  Reference	Registration	Presentation
  RK040D	CE-IVD 510(k)	96 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ HIA IgG, IgA, IgM

  Specific isotyping assay.
  Screening assay for the detection and the specific assay of heparin-dependent antibodies of IgG, IgA, IgM isotypes, responsible of heparin induced thrombocytopenia (HIT) in human plasma or serum or any other biological fluids where these antibodies must be detected.

  Reference	Registration	Presentation
  RK040E on-demand	CE-IVD	32 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ HIA MonoStrip, IgG
  32 tests

  Detection and assay of heparin-dependent antibodies of the IgG isotype (anti heparin PF4 complexes), in human plasma or serum or any other biological fluids where these antibodies must be detected.

  Reference	Registration	Presentation
  RK041A	CE-IVD 510(k)	32 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

  
• ZYMUTEST™ HIA MonoStrip, IgGAM
  32 tests

  Detection and screening assay of heparin-dependent antibodies (anti heparin PF4 complexes), responsible of heparin induced thrombocytopenia (HIT) whatever the isotype is: IgG, IgA and IgM, in human plasma or serum or any other biological fluids where these antibodies must be detected.

  Reference	Registration	Presentation
  RK041D	CE-IVD 510(k)	32 tests

  IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE