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Meridian Bioscience, Inc.
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ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT is an FDA 510(k)-cleared medical device (K123423) manufactured by Meridian Bioscience, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 4, 2013. Regulation: 8.