GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY

GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY is an FDA 510(k)-cleared medical device (K983399) manufactured by Genzyme Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 10, 1999. Regulation: 8.