Alinity m HSV 1 & 2 / VZV

Alinity m HSV 1 & 2 / VZV is an FDA 510(k)-cleared medical device (K233349) manufactured by Abbott Molecular, 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 May 2, 2024. Regulation: 8.