Biosite Diagnostics has filed for FDA 510(k) clearance to market its test for identifying Clostridium difficile, a potentially fatal bacterium, which sometimes thrives after antibiotic treatment. The Triage C difficile Panel can simultaneously detect the bacteria and the toxins they produce within 15 minutes. The company estimated that three million tests for Clostridium difficile were performed in the US in 1995.
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