
Centers for Disease Control and Prevention
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Francisella tularensis Real-time PCR Assay is an FDA 510(k)-cleared medical device (K260812) 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 March 29, 2026. Regulation: 8.