SCEPTOR GRAM-NEGATIVE URINE ISOLATE MIC/ID PANEL

SCEPTOR GRAM-NEGATIVE URINE ISOLATE MIC/ID PANEL is an FDA 510(k)-cleared medical device (K882299) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 17, 1988. Regulation: 8.