TOXOPLASMA GOND II IGG DIA TEST KIT

TOXOPLASMA GOND II IGG DIA TEST KIT is an FDA 510(k)-cleared medical device (K833829) manufactured by Labsystems, 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 April 23, 1984. Regulation: 8.