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Diasorin Molecular, LLC
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Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) is an FDA 510(k)-cleared medical device (DEN230092) manufactured by Diasorin Molecular, LLC. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 14, 2024. Regulation: 8.
