AMIZYME-LEISHMANIA SPP. TEST KIT

AMIZYME-LEISHMANIA SPP. TEST KIT is an FDA 510(k)-cleared medical device (K842526) manufactured by Amico Lab, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 27, 1984. Regulation: 8.