Elecsys Anti-HCV II (08837031190)

Elecsys Anti-HCV II (08837031190) is an FDA 510(k)-cleared medical device (K221693) manufactured by Roche 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 3, 2023. Regulation: 8.