TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560

TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 is an FDA 510(k)-cleared medical device (K874594) manufactured by Clinical Sciences, 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 March 6, 1988. Regulation: 8.