MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA

MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA is an FDA 510(k)-cleared medical device (K912408) manufactured by Meridian Diagnostics, 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 July 23, 1991. Regulation: 8.