XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020

XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 is an FDA 510(k)-cleared medical device (K031965) manufactured by Remel, 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 November 13, 2003. Regulation: 8.