Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)

Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is an FDA 510(k)-cleared medical device (K143653) manufactured by Nanosphere, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 2015. Regulation: 8.