Cepheid has announced that Health Canada issued a medical device license for Xpert GBS, for the rapid detection of Group B Streptococcus, and Xpert EV, for the rapid detection of EV-associated meningitis.
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These tests join Xpert MRSA, which received Health Canada license in January, 2008. In Mexico, Cepheid has received registration from the Secretary of Health for its GeneXpert System and Xpert MRSA, Xpert Group B Streptococcus (GBS) and Xpert enterovirus (EV) tests. The products will be distributed exclusively through IL Diagnostics in Mexico and Fisher Scientific in Canada.
Rob Koska, Cepheid’s senior vice president of worldwide commercial operations, said: Regulatory licenses and registrations are critical in our efforts to effectively penetrate these new markets. Both Canada and Mexico will now have access to all of these high medical value-added diagnostic products that are improving patient care throughout the world.
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