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Meridian Bioscience, Inc.
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ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 is an FDA 510(k)-cleared medical device (K110012) manufactured by Meridian Bioscience, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 23, 2011. Regulation: 8.