
Meridian Bioscience, Inc.
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ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT is an FDA 510(k)-cleared medical device (K112125) 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 December 4, 2011. Regulation: 8.