Monitoring Anticoagulant

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 mL
221013	CE-IVD	R1: 3 x 3 mL R2: 3 x 3 mL
221015	CE-IVD	R1: 4 x 5 mL R2: 4 x 5 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

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

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

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 mL
221006	CE-IVD 510(k)	R1: 4 x 6 mL R2: 4 x 6 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

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 assays

Reference	Registration	Presentation
AR032A on-demand	CE-IVD	1 x 20 mL
AR032K	CE-IVD	4 x 20 mL

IFU APPLICATION SDS COT TABLE OF ASSIGNED VALUE

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.

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.

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.

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

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Monitoring Anticoagulant