GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF

GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF is an FDA 510(k)-cleared medical device (K081064) manufactured by Ivd Research, 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 January 13, 2009. Regulation: 8.