QUANTA LITE TOXOPLASMA IGG

QUANTA LITE TOXOPLASMA IGG is an FDA 510(k)-cleared medical device (K971441) manufactured by Inova Diagnostics, 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 December 1, 1997. Regulation: 8.