
Bio-Rad Laboratories
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BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM is an FDA 510(k)-cleared medical device (K090409) 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 May 7, 2009. Regulation: 8.