VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)

VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) is an FDA 510(k)-cleared medical device (K142033) manufactured by Nanospere,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 October 9, 2014. Regulation: 8.