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Bio-Rad Laboratories
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BIOPLEX 2200 MMRV IGG is an FDA 510(k)-cleared medical device (K091616) manufactured by Bio-Rad Laboratories. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 28, 2010. Regulation: 8.