NEW YORK (GenomeWeb News) – Life Technologies today said that its 7500 Fast Dx Real-Time PCR instrument has gained the IVD Mark in the European Union.
The firm said that the system, made by its Applied Biosystems business, is now available as a platform suitable for in vitro diagnostic use in Europe. The system was cleared for marketing in the US by the Food and Drug Administration in September 2008.
"IVD validation for the 7500 Fast Dx Real-Time PCR Instrument extends the reach of our industry-leading molecular detection technology in Europe beyond research labs and into clinical and diagnostic markets," John Gerace, VP and general manager of PCR Systems for Life Technologies, said in a statement.