
bioMerieux, Inc.
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VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE is an FDA 510(k)-cleared medical device (K103752) manufactured by bioMerieux, 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 October 13, 2011. Regulation: 8.