MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN

MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN is an FDA 510(k)-cleared medical device (K981199) manufactured by Dade Microscan, 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 November 17, 1998. Regulation: 8.