VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST

VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST is an FDA 510(k)-cleared medical device (K083088) 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 April 30, 2009. Regulation: 8.