B. anthracis Real-time PCR Assay

B. anthracis Real-time PCR Assay is an FDA 510(k)-cleared medical device (K192871) manufactured by Centers for Disease Control and Prevention. 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 6, 2019. Regulation: 8.