ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST

ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST is an FDA 510(k)-cleared medical device (K883936) manufactured by Ortho Diagnostic Systems, 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 5, 1988. Regulation: 8.