ADVIA Centaur Toxoplasma M (Toxo M)

ADVIA Centaur Toxoplasma M (Toxo M) is an FDA 510(k)-cleared medical device (K142826) manufactured by Siemens Healthcare Diagnostics, 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 December 21, 2015. Regulation: 8.