COPALIS TORC TOTAL ANTIBODY ASSAY

COPALIS TORC TOTAL ANTIBODY ASSAY is an FDA 510(k)-cleared medical device (K970931) manufactured by Sienna Biotech, 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 April 23, 1997. Regulation: 8.