The SensiTox B. anthracis Toxin Test

The SensiTox B. anthracis Toxin Test is an FDA 510(k)-cleared medical device (K232545) manufactured by First Light 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 November 19, 2023. Regulation: 8.