UPDATE: Quidel Wins FDA Clearance for Sofia (R) Strep A Fluorescent

Quidel Corporation QDEL, a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Sofia Strep A fluorescent immunoassay for use on the Sofia Analyzer for the rapid, objective detection of infections by Group A Streptococcus bacteria. These bacteria are the most common cause of bacterial pharyngitis and can also cause rheumatic fever and other potentially serious illnesses.
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