IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96

IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 is an FDA 510(k)-cleared medical device (K031059) 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 July 9, 2003. Regulation: 8.