
Focus Diagnostics, Inc.
Free shipping on orders over $99 · 30-day returns
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK is an FDA 510(k)-cleared medical device (K120413) manufactured by Focus Diagnostics, 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 12, 2012. Regulation: 8.