
Bayer Diagnostics Corp.
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ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY is an FDA 510(k)-cleared medical device (K010050) manufactured by Bayer Diagnostics Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 4, 2001. Regulation: 8.