ARTUS INFL A/B RG RT-PCR KIT

ARTUS INFL A/B RG RT-PCR KIT is an FDA 510(k)-cleared medical device (K113323) manufactured by QIAGEN GmbH. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 5, 2012. Regulation: 8.