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www.fdanews.com/articles/108882-ortho-developing-next-generation-diagnostic-system

Ortho Developing Next Generation Diagnostic System

July 25, 2008

Ortho Clinical Diagnostics has submitted its Vitros 5600 Integrated System for FDA 510(k) clearance.

The system integrates immunoassay testing and clinical chemistry to perform more than 100 different assays. Whereas other systems require samples to be removed and analyzed in separate modules, the product can manage various samples simultaneously and does not require them to be sent to separate processing centers, the company said.

Pending FDA clearance, the system will be marketed in the U.S. and other countries with similar regulatory bodies.