VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)

VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) is an FDA 510(k)-cleared medical device (K120466) manufactured by Nanosphere, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 5, 2012. Regulation: 8.