MEDFORD, NY--(MARKET WIRE)--Sep 25, 2007 -- Chembio Diagnostics, Inc. (OTC BB:CEMI.OB - News) has received certification under ISO 13.485: 2003. ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards. It is comprised of a network of the national standards institutes of 155 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements; in particular, it specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. ISO 13.485 is the quality system that is most recognized throughout the European Community for products seeking a CE marking. Chembio has engaged a European Notified Body in connection with its plans to obtain a CE marking for its products.
