First PARSEC(TM) System in U.S. Installed For Evaluation Testing
Miami, FL - IVAX Diagnostics, Inc. announced recently that all documentation required by the European Community Directive 98/79/CE on in vitro diagnostic medical devices has been completed by Delta Biologicals S.r.l. for the production of the PARSEC(TM) System instrument. Delta Biologicals is based in Pomezia, Italy and is a wholly owned subsidiary of IVAX Diagnostics. By completing this process, IVAX Diagnostics is permitted to make declarations of CE conformity when the PARSEC(TM) System instrument is marketed in countries where CE certification is sufficient for the release of in vitro diagnostic medical devices.
IVAX Diagnostics will be displaying the PARSEC(TM) System at the XIX International Congress of Clinical Chemistry and the 2005 Annual Meeting of the American Association for Clinical Chemistry (AACC) and Clinical Lab Expo to be held in Orlando from July 26-28, 2005. The organizers of this year's meeting indicate that the Clinical Lab Expo contains more companies in more booths than any other clinical laboratory exposition in the world.
IVAX Diagnostics also announced recently that it has recently placed its first PARSEC(TM) System in the United States for evaluation testing at a customer site.
Giorgio D'Urso, CEO and President of IVAX Diagnostics, said, "We are very excited about our ability to market the PARSEC(TM) System with CE conformity. We expect to begin making deliveries of the PARSEC(TM) System in international markets starting in the third quarter and in the U.S. during the fourth quarter. The Clinical Lab Expo held in Orlando gives us the best opportunity to present this new system to laboratory customers from around the world. We are very encouraged by the great deal of interest generated to date in this new laboratory automation system. We have installed a PARSEC(TM) System in an influential U.S. customer site for evaluation testing that will assist us as we prepare for our commercial launch which is expected later this year."
SOURCE: IVAX Diagnostics, Inc.