SERAQUEST TOXOPLASMA IGM

SERAQUEST TOXOPLASMA IGM is an FDA 510(k)-cleared medical device (K971672) manufactured by Quest Intl., 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 October 20, 1997. Regulation: 8.