ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT

ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT is an FDA 510(k)-cleared medical device (K933878) manufactured by Intracel Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 13, 1995. Regulation: 8.