Hemophilia, von Willebrand Disease and Other Bleeding Disorders

Reagents for Heparins & their Analogues

BIOPHEN™ Heparin LRT CE-IVD Chromogenic as say for quantitative determination of anti-Xa activity. Liquid reagent, BIOPHEN™ Heparin LRT CE-IVD ready to use. 221011 R1,R2: 4x7.5mL
221013 R1,R2: 3 x3mL
221015 R1, R2: 4x5mL
BIOPHEN™ Heparin CE-IVD
510(k)
Chromogenic as say for quantitative determination of anti-Xa activity. Lyophilized reagent. 221003 R1, R2: 3x3mL
221006 R1, R2: 4x6mL
BIOPHEN™ Heparin (AT+) RUO Chromogenic as say for quantitative determination of anti-Xa activity, us ing exogenous AT s ource. 221007 R1, R2: 2x7.5mL
R3: 2x2.5mL
BIOPHEN™ Anti-Xa
(2 Stages Heparin Assay)
RUO Two s tages Anti-Xa chromogenic method for the Heparin activity measurement on plas ma or purified medium, according to Pharmacopeia. 221005 R1, R2, R3: 2 x 1 mL
BIOPHEN™ Anti-IIa
(2 Stages Heparin Assay)
RUO Two s tages chromogenic method for the Heparin anti- IIa activity measurement on plas ma or purified medium, according to Pharmacopeia. 220005 R1, R2, R3: 2 x 1 mL
BIOPHEN™ Heparin Anti-IIa
(kinetics)
RUO Chromogenic Kinetic as say for quantitative determination of anti-IIa activity for purified fluids . 221020 R1:2x5mL
R2, R3: 2x10mL ; R4: 2x20mL

Reagents for Direct Factor Xa Inhibitors (DiXaIs)

BIOPHEN™ Heparin LRT CE-IVD Chromogenic as say for quantitative determination
of anti-Xa activity. Liquid reagent, ready to use.
221011 R1, R2: 4x7.5mL
221013 R1, R2: 3x3mL
221015 R1, R2: 4x5mL
BIOPHEN™ Heparin CE-IVD
510(k)
Chromogenic as say for quantitative determination
of anti-Xa activity. Lyophilized reagent.
221003 R1, R2: 3x3mL
221006 R1, R2: 4x6mL
BIOPHEN™ DiXaI CE-IVD Chromogenic as say for quantitative determination
of anti-Xa activity. Specific for DiXaIs .
221030 R1, R2: 3x2.5mL
R3 : 4x20mL

Dilution Buffer

Special dilution buffer reducing heparin interferences for anti-Xa chromogenic assays

Tris NaCl EDTA buffer, pH 7.85 RUO Buffers for NEW chromogenic as says . AR032A 4 x 20 mL
AR032K 4 x 20 mL

Reagents for Direct Thrombin Inhibitors (DTIs)

HEMOCLOT™ Thrombin Inhibitors CE-IVD Clotting as say for quantitative determination of DTI activity CK002K R1,R2: 3x1mL
CK002L R1,R2: 3x2.5mL
BIOPHEN™ DTI CE-IVD Chromogenic as say for quantitative determination of DTI activity. Specific to DTIs 220202 R1,R2,R3: 2x2.5mL

Reagents for the detection of Heparin Induced Thrombocytopenia (HIT)

Standardised ELISA method optimised for the detection of Heparin-dependent Antibodies in human plasma, serum or any biological fluid, allowing confirmation of HIT/HITT diagnosis or its clinical suspicion

Screening

ZYMUTEST™ HIA IgGAM CE-IVD
510(k)
ELISA method for detection of heparin dependent antibody IgGAM RK040D 96 tes ts
ZYMUTEST™ HIA MonoStrip, IgGAM CE-IVD
510(k)
ELISA method for detection of heparin dependent antibody IgGAM, monostrip RK041D 4 x 8 tes ts

Isotyping

ZYMUTEST™ HIA IgG CE-IVD
510(k)
ELISA method for detection of heparin dependent antibody IgG. RK040A 96 tests
ZYMUTEST™ HIA Mono Strip, IgG CE-IVD
510(k)
ELISA method for detection of heparin dependent antibody IgG, monostrip RK041A 4 x 8 tests
ZYMUTEST™ HIA IgA CE-IVD ELISA method for detection of heparin dependent antibody IgA. RK040C
on-demand
96 tests
ZYMUTEST™ HIA IgM CE-IVD ELISA method for detection of heparin dependent antibody IgM. RK040B
on-demand
96 tests
ZYMUTEST™ HIA IgG, IgA, IgM CE-IVD
ELISA method for detection of heparin dependent antibody IgG, IgA or IgM. RK040E on-demand 96 tests