MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)

MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) is an FDA 510(k)-cleared medical device (K190109) manufactured by Beckman Coulter, 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 April 17, 2019. Regulation: 8.