Elecsys Anti-HAV IgM

Elecsys Anti-HAV IgM is an FDA 510(k)-cleared medical device (K260048) 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 April 6, 2026. Regulation: 8.