PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION

PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION is an FDA 510(k)-cleared medical device (K922010) manufactured by Alexon, 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 June 18, 1992. Regulation: 8.