CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY

CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K864315) manufactured by Cytotech, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 1, 1987. Regulation: 8.