
Nanosphere, Inc.
Free shipping on orders over $99 · 30-day returns
VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST is an FDA 510(k)-cleared medical device (K070804) 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 September 16, 2007. Regulation: 8.