BIO-RAD PLATELIA TOXO IGM TMB

BIO-RAD PLATELIA TOXO IGM TMB is an FDA 510(k)-cleared medical device (K013837) manufactured by Bio-Rad. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 29, 2002. Regulation: 8.