TOXOPLASMA GONDII IGG ELISA

TOXOPLASMA GONDII IGG ELISA is an FDA 510(k)-cleared medical device (K871905) manufactured by Electro-Nucleonics Laboratories, 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 July 29, 1987. Regulation: 8.