
Bayer Corp.
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BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY is an FDA 510(k)-cleared medical device (K010668) manufactured by Bayer Corp.. 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 4, 2001. Regulation: 8.