Monitoring Anticoagulant
No description for this category
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BIOPHEN™ Heparin LRTLiquid and Ready to use
One stage, kinetics anti-Xa method for the measurement of heparin (UFH, LMWH), its analogs (Arixtra®/Fondaparinux and Orgaran®/Sodium Danaparoïd), or direct anti-FXa drugs in human citrated plasma. This method is appropriate for the direct Factor Xa (FXa) inhibitors: Apixaban, Rivaroxaban, and Edoxaban.
Reference Registration Presentation 221011 CE-IVD R1: 4 x 7.5 mL
R2: 4 x 7.5 mL221013 CE-IVD R1: 3 x 3 mL
R2: 3 x 3 mL221015 CE-IVD R1: 4 x 5 mL
R2: 4 x 5 mL -
BIOPHEN™ DiXaI
Two-stage, chromogenic anti-Xa method for the measurement of direct Factor Xa inhibitors (DiXaIs), such as Rivaroxaban, Apixaban or Edoxaban, in citrated human plasma (or purified medium). This method is not suitable for indirect inhibitors such as heparins or Fondaparinux.
Reference Registration Presentation 221030 CE-IVD R1: 3 x 2.5 mL
R2: 3 x 2.5 mL
R3 : 4 x 20 mL -
BIOPHEN™ Heparin (AT+)
Kinetics assay for measuring the concentration of heparin, and heparin-like anticoagulants, in human citrated plasma or in any other biological fluid, using an anti-Xa chromogenic method, with the addition of Antithrombin (AT), when endogenous AT concentration is insufficient for measuring heparin.
Reference Registration Presentation 221007 RUO R1: 2 x 7.5 mL
R2: 2 x 7.5 mL
R3: 2 x 2.5 mL -
BIOPHEN™ Anti-Xa(2 Stages Heparin Assay)
Two stages chromogenic anti-Xa method for measuring the activity of heparins (UFH or LMWH), in presence of a constant amount of AT, in compliance with Pharmacopeias. This method can be used for testing heparin in human citrated plasma, or in purified solutions.
Reference Registration Presentation 221005 RUO R1: 2 x 1 mL
R2: 2 x 1 mL
R3: 2 x 1 mL -
BIOPHEN™ Anti-IIa(2 Stages Heparin Assay)
Two stages chromogenic anti-IIa assay for measuring the activity of heparins (UFH or LMWH), in presence of a constant amount of AT, in compliance with Pharmacopeias. This method can be used for testing heparin in human citrated plasma, or in purified solutions.
Reference Registration Presentation 220005 RUO R1: 2 x 1 mL
R2: 2 x 1 mL
R3: 2 x 1 mL -
BIOPHEN™ Heparin Anti-IIa(kinetics)
One stage, kinetics anti-IIa method for measuring the concentration of heparin, and heparin-like anticoagulants. This method is proposed for testing heparin in buffer, or purified systems. Not suitable for testing plasma.
Reference Registration Presentation 221020 RUO R1: 2 x 5 mL
R2: 2 x 10 mL
R3: 2 x 10 mL
R4: 2 x 20 mL -
BIOPHEN™ Heparin: lyophilized reagents
Determination of heparin and heparin like anticoagulants. Using an anti-Xa method.
Reference Registration Presentation 221003 CE-IVD
510(k)R1: 3 x 3 mL
R2: 3 x 3 mL221006 CE-IVD
510(k)R1: 4 x 6 mL
R2: 4 x 6 mL -
Tris NaCl EDTA buffer, pH 7.85
Special dilution buffer for anti-Xa chromogenic assays, especially using BIOPHEN™ DiXaI kit (221030) or BIOPHEN™ Heparin LRT kits (221011/221013/221015).
Special dilution buffer reducing heparin Interferences for anti-Xa chromogenic assaysReference Registration Presentation AR032A on-demand CE-IVD 1 x 20 mL AR032K CE-IVD 4 x 20 mL
No description for this category
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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 mLCK002L CE-IVD R1: 3 x 2.5 mL
R2: 3 x 2.5 mL -
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
Measurement of heparin dependent antibodies.
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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 -
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-demandCE-IVD 96 tests -
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-demandCE-IVD 96 tests -
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 -
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-demandCE-IVD 32 tests -
ZYMUTEST™ HIA MonoStrip, IgG32 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 -
ZYMUTEST™ HIA MonoStrip, IgGAM32 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