FDAnews Device Daily Bulletin

MARK CERTIFICATION SMART EBV IN VITRO DIAGNOSTIC TEST FOR SMARTCYCLER PLATFORM CEPHEID LAUNCHES CE

May 16, 2006
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Cepheid, a broad-based molecular diagnostics company, today announced the European release of the Smart EBV (Epstein-Barr Virus) Assay for clinical diagnostic use on the SmartCycler System. The EBV assay was released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Smart EBV is intended for rapid detection and quantitation of EBV viral load. PR Newswire (http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/05-15-2006/0004361164&EDATE=)