PROSPEC T GIARDIA MICROTITER ASSAY

PROSPEC T GIARDIA MICROTITER ASSAY is an FDA 510(k)-cleared medical device (K930451) 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 April 20, 1993. Regulation: 8.