PLATELIA TOXO IGM KIT MODEL 26211

PLATELIA TOXO IGM KIT MODEL 26211 is an FDA 510(k)-cleared medical device (K090847) manufactured by Bio-Rad Laboratories. 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 30, 2009. Regulation: 8.