LMD GIARDIA ANTIGEN DETECTION ASSAY

LMD GIARDIA ANTIGEN DETECTION ASSAY is an FDA 510(k)-cleared medical device (K944871) manufactured by Lmd Laboratories. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 21, 1995. Regulation: 8.