CEP 8 SPECTRUMORANGE DNA PROBE KIT

CEP 8 SPECTRUMORANGE DNA PROBE KIT is an FDA 510(k)-cleared medical device (K953591) manufactured by Vysis. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 28, 1996. Regulation: 8.