Rickettsia Real-time PCR Assay

Rickettsia Real-time PCR Assay is an FDA 510(k)-cleared medical device (K170940) manufactured by Centers For Disease Control and Prevention (CDC). This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 28, 2017. Regulation: 8.