IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96

IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 is an FDA 510(k)-cleared medical device (K020583) 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 September 16, 2002. Regulation: 8.