CRAG LATERAL FLOW ASSAY (LFA)

CRAG LATERAL FLOW ASSAY (LFA) is an FDA 510(k)-cleared medical device (K112422) manufactured by Immuno-Mycologics, 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 March 27, 2012. Regulation: 8.