INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY

INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY is an FDA 510(k)-cleared medical device (K963289) manufactured by Incstar Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 1997. Regulation: 8.