SAN DIEGO, CA – November 22, 2004 - Diazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology® (STE) platform to develop low cost and high quality diagnostic products for clinical and research uses, announced today that on November 17, 2004, the Company's application for CE Marking for the Homocysteine, Lithium, Sodium, and Potassium Assays in accordance with EU Directive 98/79/EC was approved. CE Mark approval allows the Company to market all four products for clinical laboratory use in all member countries of the European Union. Additionally, many other countries outside of the European Union recognize the CE Mark for regulatory approval to market medical devices.
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices applies to in vitro diagnostic medical devices and their accessories. These devices are products used for the in vitro analysis of tissues or substances (blood, specimens) from the human body. The types of analysis covered are as follows: state of health; congenital diseases or anomalies; checking the progress of courses of treatment; and determining compatibility in the case of organ or blood donations. The Directive lays down the objectives or "essential requirements" of safety, health, design and manufacture which must be met by in vitro diagnostic medical devices when they are manufactured and placed on the market.
Diazyme has chosen Medical Device Safety Service (MDSS) located in Hanover, Germany, as its authorized representative. MDSS specializes in European Regulatory Affairs, and assisted Diazyme in meeting compliance with directive (IVD) 98/79/EC.
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