BACTIDROP(TM) INDOLE (KOVACS)

BACTIDROP(TM) INDOLE (KOVACS) is an FDA 510(k)-cleared medical device (K913009) manufactured by Remel Co.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 17, 1991. Regulation: 8.