CRYPTOSPORIDIUM ANTIGEN DETECTION

CRYPTOSPORIDIUM ANTIGEN DETECTION is an FDA 510(k)-cleared medical device (K905598) 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 September 4, 1991. Regulation: 8.