TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)

TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) is an FDA 510(k)-cleared medical device (K862216) 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 June 29, 1986. Regulation: 8.