VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)

VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) is an FDA 510(k)-cleared medical device (K140083) 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 June 19, 2014. Regulation: 8.