BioPlex 2200 Lyme Total

BioPlex 2200 Lyme Total is an FDA 510(k)-cleared medical device (K183446) 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 March 11, 2019. Regulation: 8.