MICROSCAN(R) MICROSTREP PLUS(R)

MICROSCAN(R) MICROSTREP PLUS(R) is an FDA 510(k)-cleared medical device (K111677) manufactured by Siemens Healthcare Diagnostics, 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 August 3, 2011. Regulation: 8.