TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM

TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM is an FDA 510(k)-cleared medical device (K955760) manufactured by Bayer 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 August 1, 1996. Regulation: 8.