PROSPECT CRYPTOSPORIDIUM RAPID ASSAY

PROSPECT CRYPTOSPORIDIUM RAPID ASSAY is an FDA 510(k)-cleared medical device (K936191) manufactured by Alexon Biomedical, 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 16, 1994. Regulation: 8.