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A SUPPORT FOR EQA (EXTERNAL QUALITY ASSESSMENT)
With the company s recognized experience, its offer for a full range of calibrators and controls, and its high-capacity manufacturing equipment, HYPHEN BioMed can provide you with lyophilized plasma materials for external quality assessment (EQA) organizations.
HYPHEN BioMed can meet your expectations with normal or pathological samples for routine hemostasis assays, or anticoagulation monitoring (e.g. heparins and heparin-like spiked samples, direct anti-Xa or anti-IIa inhibitors spiked in plasma, ).
HYPHEN BioMed offers a complete and flexible line of assayed parameters, at targeted levels, and pre-titrated samples, which can be used on the major automated coagulation analyzers.
REGULATORY STATUS (RS)
RUO For Research Use Only. Should not be used for patient diagnosis or treatment. CE-IVD CE marked product In-Vitro Diagnostic use. 510(k) United States marked product for IVD use
QUALITY SYSTEM
One of the company s major objectives is to achieve excellence in the quality of products, services and support by adhering to international quality standards. HYPHEN BioMed is certified for: ISO 13485:2016, MDSAP (Medical Device Single Audit Program) by TÜV Rheinland, and the company started the transition to the European regulation (EU) 2017/746.
All basic objectives and commitments of each HYPHEN BioMed employee are dedicated to deliver to customers full satisfaction through the quality of products and services.
HYPHEN BioMed develops and markets diagnostic reagents, many of which are CE marked and 510(k) cleared. They concern clotting, chromogenic and immunological assays for measuring all anticoagulant drugs, blood extracts and monitoring substitutive therapies, as well as all which is needed for thrombosis check-up and hemostasis laboratory applications.
SYSTEMS
HYPHEN BioMed s assays can be applied to all current coagulation analyzers such as Sysmex CA series, CS series, CN series or Werfen ACL TOP® Family, Stago STA® R series.
HYPHEN BioMed provides Application Guides for defined coagulation analyzer families. The Application Guides contain analyzer/assay specific handling and performance information and supersede the information from the Instructions for Use.
CS-1600 CS-5100CS-2400 CS-2500
CN Series
GLOBAL & ROUTINE TESTS .........................................................9
PRIMARY HEMOSTASIS ...................................................................17
BLEEDING DISORDERS ...................................................................23
THROMBOPHILIA ....................................................................................35
MONITORING ANTICOAGULANT .......................................53
FIBRINOLYSIS ................................................................................................69
CALIBRATORS & CONTROLS ...................................................77
RESEARCH .........................................................................................................87
AUXILIARY REAGENTS ...................................................................109
INDEX .....................................................................................................................119
CONTENTS