CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY

CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K863363) 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 November 12, 1986. Regulation: 8.