Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is an FDA 510(k)-cleared medical device (K221834) 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 June 23, 2022. Regulation: 8.