Alinity m EBV (09N43-095)

Alinity m EBV (09N43-095) is an FDA 510(k)-cleared medical device (K243489) 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 July 27, 2025. Regulation: 8.