ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII is an FDA 510(k)-cleared medical device (K952818) manufactured by Pyramid Biological 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 November 19, 1995. Regulation: 8.