
Nanosphere, Inc.
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VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST is an FDA 510(k)-cleared medical device (K122514) 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 September 18, 2012. Regulation: 8.