INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)

INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) is an FDA 510(k)-cleared medical device (K963296) 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 December 15, 1996. Regulation: 8.