Bio/Data Corporation receives Health Canada licences.HORSHAM, Pa. -- Bio/Data Corporation ("Bio/Data"), suburban Philadelphia-based developer, manufacturer and provider of hemostasis 1. the arrest of bleeding by the physiological properties of vasoconstriction and coagulation or by surgical means. 2. interruption of blood flow through any vessel or to any anatomical area. he·mo·sta·sis (h products, announced it has received Class II medical device licences from Health Canada, and that Bio/Data will immediately promote its aggregation instruments, reagents and disposables in Canada's 10 provinces and three territories. Bio/Data's ISO 13485:2003 quality system certification, earned in late July 2006, was a prerequisite for the Company's latest milestone. Subsequently, Health Canada issued medical device licences for Bio/Data's Platelet Aggregation Profiler[R] instruments and its vW Factor Assay[R] (von Willebrand Factor Assay). "Platelet aggregation testing is becoming more important each year," said William M. Trolio, vice president of the 37-year-old Philadelphia-area privately owned company. "And Health Canada's goal is for Canada to be among the countries with the healthiest people in the world. These Health Canada licenses recognize that our quality system conforms to world-class standards." The behavior of platelets (the profile of aggregation) allows physicians to diagnosis genetic and acquired bleeding disorders, clotting disorders and monitor anti-platelet therapy. The importance of standardizing results led the Company to develop and manufacture its first line of aggregation reagents in 1975. AggRecetin[TM], the Company's brand name for Ristocetin sulfate, was added to the Company's quality reagent product line in 1978. Bio/Data then created a von Willebrand Factor Assay (also known as Ristocetin Cofactor heparin cofactor II a serine proteinase inhibitor of the serpin family that inhibits thrombin. co·fac·tor (k ![]() f Assay) kit, and it has grown in usage and popularity. Bio/Data's PAP-8E is a modern laboratory instrument utilized for testing platelet function. Test results provide a vital pathway enabling medical professionals to diagnose various stages of hemostasis disorders, including von Willebrand Disease, hemophilia and Glanzmann's disease, or to monitor the use of antiplatelet an·ti·plate·let ( n t -pl t drugs like Plavix([R]) and aspirin. Other Bio/Data products consist of disposables to augment a variety of platelet testing. Bio/Data's web address is www.biodatacorp.com. The company's aggregation products are CE marked. |
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