Bio/Data Corporation receives Health Canada licences.HORSHAM, Pa. -- Bio/Data Corporation ("Bio/Data"), suburban Philadelphia-based developer, manufacturer and provider of hemostasis hemostasis /he·mo·sta·sis/ (he?mo-sta´sis) (he-mos´tah-sis) 1. the arrest of bleeding by the physiological properties of vasoconstriction and coagulation or by surgical means. 2. 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 (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 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 Platelet aggregation The clumping together of blood cells, possibly forming a clot. Mentioned in: Herbalism, Traditional Chinese Profiler[R] instruments and its vW Factor Assay[R] (von Willebrand Factor von Willebrand factor (vWF) A protein found in the blood that is involved in the process of blood clotting. Mentioned in: Von Willebrand Disease 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 sulfate, chemical compound containing the sulfate (SO4) radical. Sulfates are salts or esters of sulfuric acid, H2SO4, formed by replacing one or both of the hydrogens with a metal (e.g., sodium) or a radical (e.g., ammonium or ethyl). , 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 cofactor An atom, organic molecule, or molecular group that is necessary for the catalytic activity (see catalysis) of many enzymes. A cofactor may be tightly bound to the protein portion of an enzyme and thus be an integral part of its functional structure, or it may 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 Von Willebrand Disease Definition Von Willebrand disease is caused by a deficiency or an abnormality in a protein called von Willebrand factor and is characterized by prolonged bleeding. , hemophilia and Glanzmann's disease, or to monitor the use of antiplatelet 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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