
Bio-Rad Laboratories, Inc.
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BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 is an FDA 510(k)-cleared medical device (K041658) manufactured by Bio-Rad Laboratories, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 19, 2004. Regulation: 8.