GONOSTAT GONOCOCCAL DETECTION KIT

GONOSTAT GONOCOCCAL DETECTION KIT is an FDA 510(k)-cleared medical device (K991268) manufactured by Sierra Diagnostics. 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 10, 1999. Regulation: 8.