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Article: Focus Submits West Nile Virus Diagnostic Kits to FDA for 510(k) Clearance.
- Article from:
- PR Newswire
- Article date:
- June 25, 2003
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HERNDON, Va. -- HERNDON, Va., June 25 /PRNewswire/ -- Today Focus Technologies announced that it has completed clinical trials on its West Nile Virus (WNV) IgG and IgM ELISA diagnostic kits and has filed a 510(k) application with FDA. This is an important development as there are currently no West Nile Virus FDA-cleared kits on the U.S. market. Focus' products are based on protein antibody technology licensed from the Centers for Disease Control and Prevention (CDC).
Experts believe that 2003 could be a heavy season for West Nile Virus cases in the U.S. According to CDC, 294 people died of the disease in 2002 and there were over 4,000 confirmed cases. Last ...