MONOLISA ANTI-HAV IGM EIA

MONOLISA ANTI-HAV IGM EIA is an FDA 510(k)-cleared medical device (K092353) manufactured by Bio-Rad Laboratories, 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 October 28, 2009. Regulation: 8.