
Roche Diagnostics/Boehringer Mannheim GmbH
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CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY is an FDA 510(k)-cleared medical device (K981931) manufactured by Roche Diagnostics/Boehringer Mannheim GmbH. 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 August 24, 1998. Regulation: 8.