Xpect® Flu A&B IFU with FDA clearance to include new analytical reactivity information for the 2009 H1N1.
The Xpect® Flu A&B Instructions for Use (package insert) has been revised to include additional analytical reactivity information for two H1N1 strains including the 2009 H1N1 Influenza A/California/04/2009.
Although Xpect Flu A&B has been shown to detect the novel influenza (H1N1) virus in cultured isolates from a positive human specimen, the performance characteristics of the device with human specimens infected with the 2009 H1N1 influenza virus have not been established. Xpect Flu A&B can distinguish between influenza A and B viruses, but it does not differentiate influenza subtypes.
About Remel
Remel, part of Thermo Fisher Scientific, is a global provider of a wide range of high quality microbiology products used by clinical, industrial, research, and academic laboratories. We are a world leader in the manufacture and distribution of dehydrated and prepared culture media, collection and transport systems, diagnostic and rapid direct specimen tests, quality control products and much more. An extensive product portfolio, which includes trusted, market-leading names and superior performance, is complemented by a team of experts dedicated to providing the highest levels of technical service and customer support. Our people take great pride in providing quality products, rapid delivery, and superior support and are committed to exceeding customer expectations. Now, as a brand of Thermo Fisher Scientific, the world leader in serving science, we are even better positioned to deliver the science, service, and solutions our laboratory customers need to get the job done.