MDx-Chex for BCID2

MDx-Chex for BCID2 is an FDA 510(k)-cleared medical device (K212576) manufactured by Streck, 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 January 18, 2022. Regulation: 8.