
Roche Professional Diagnostics
Free shipping on orders over $99 · 30-day returns
ANTI-HAV is an FDA 510(k)-cleared medical device (K100903) manufactured by Roche Professional 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 October 4, 2010. Regulation: 8.