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CE Marking For High Throughput Blood Screening PROCLEIX® TIGRIS® System

Chiron Corporation and Gen-Probe Incorporated have announced that the PROCLEIX® ULTRIO™ Assay for use on the PROCLEIX®TIGRIS® System has been granted the CE (Conformite Europeene) Mark in accordance with Directive 98/79/EC. With the CE Mark, the companies can now proceed with the commercialization of the PROCLEIX TIGRIS System in the European Union, as well as in other parts of the world that accept the CE Mark.

The fully automated, high-throughput PROCLEIX TIGRIS System can process 1,000 blood samples in under 14 hours, facilitating testing in smaller pool sizes and individual donor testing.

The approval allows the already CE Marked PROCLEIX ULTRIO Assay to be run on the fully automated, high-throughput PROCLEIX TIGRIS System. The PROCLEIX ULTRIO Assay was developed to simultaneously detect human immunodeficiency virus, type 1 (HIV-1), hepatitis C virus (HCV) and hepatitis B virus (HBV) in specimens from donated blood, plasma, organs and tissue.

NOTE: This item is from our 'historic' database and may contain information which is not up to date.

Source : Gen-Probe, Inc View archived contact details

Posted on December 20, 2004