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Quidel Corp Receives FDA Clearance for Sofia hCG Fluorescent Immunoassay (FIA)-DJ

Monday, 5 Aug 2013 06:00pm EDT 

Dow Jones reported that Quidel Corporation received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Sofia hCG fluorescent immunoassay for use on the Sofia Analyzer for the rapid, objective detection of elevated levels of human chorionic gonadotropin ( hCG), an early indicator of pregnancy. The 510(k) clearance allows Quidel to market and sell its new Sofia hCG FIA in the United States. 

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3 Mar 2015