PROSPEC T/GIARDIA RAPID ASSAY

PROSPEC T/GIARDIA RAPID ASSAY is an FDA 510(k)-cleared medical device (K911337) 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 September 26, 1991. Regulation: 8.