TXOCELL-IHA REAGENT SYSTEM

TXOCELL-IHA REAGENT SYSTEM is an FDA 510(k)-cleared medical device (K790460) manufactured by Calbiochem-Behring Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 24, 1979. Regulation: 8.