
Centers for Disease Control and Prevention
Free shipping on orders over $99 · 30-day returns
Francisella tularensis Real-time PCR assay is an FDA 510(k)-cleared medical device (K252072) manufactured by Centers for Disease Control and Prevention. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 29, 2025. Regulation: 8.