Hyphen Biomed

Contact: Jean Amiral
Web: http://www.hyphen-biomed.com
Address: 155 Rue D' Eragny, Zac Neuville-Universite, Neuville Sur Oise 95000, France
Phone: +33-(1)-34406510 | Fax: +33-(1)-34487236 | Map/Directions >>

Profile: Hyphen Biomed provides diagnostic and research reagents and biochemicals for the exploration of thrombosis, hemostasis, fibrinolysis and auto-immunity. We offer a full line of kits, manual or automated, designed with clotting, and chromogenic-immunological methods for use in laboratory testing, biomedical or epidemiological studies, research protocols and customized applications for biotechnologies and the pharmaceutical industry. Our products include HIT (IVD/CE), diagnosis CE, blood microparticles research kits, biochemicals and veterinary products. Our HIT (IVD/CE) comprises HIT confirmation HIT risk assessment and research applications. We develop zymutest HIA, IgG (CE) for the specific measurement of heparin dependent antibodies of the IgG isotype. Our zymutest Ag Two-site ELISA method is useful for the measurement of PAI-1 antigen, that is plasminogen-activator-inhibitor 1. Our zymuphen MP-activity, a product of blood microparticles, is a complete kit for the quantitative measurement of blood circulating micro-particle's procoagulant activity.

FDA Registration Number: 3004434070
US Agent: Sandra White / Aniara Diagnostica Llc
Phone: +1-(513)-770-1991 Fax: +1-(513)-573-9241 E-Mail:

16 Products/Services (Click for related suppliers)

• Abnormal Plasma Control (FDA Code: GGC / 864.5425)

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

• Antithrombin III Quantitation Test (FDA Code: JBQ / 864.7060)

An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

• Cellular Imaging & Analysis

• Cellular Imaging Systems

• ELISA Immunoassay Kits, Total Human IgA

• ELISA Immunoassay Kits, Total Human IgE

• Fibrinogen Control Plasma (FDA Code: GIL / 864.7340)

A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

• Fibrinogen Determination System Test (FDA Code: KQJ / 864.7340)

• Fibrinogen Test (FDA Code: GIS / 864.7340)

• Heparin Assay (FDA Code: KFF / 864.7525)

A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).

• Partial Thromboplastin Test Time (FDA Code: GGW / 864.7925)

A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

• Plasma Coagulation Control (FDA Code: GGN / 864.5425)

• Platelet Factor 4 Radioimmunoassay (FDA Code: LCO / 864.7695)

A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.

• Qualitative and Quantitative Factor Deficiency Test (FDA Code: GGP / 864.7290)

A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).

• Secondary Calibrator (FDA Code: JIT / 862.1150)

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.)

• Thrombin (FDA Code: GJB / 864.7875)

A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.