VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96

VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 is an FDA 510(k)-cleared medical device (K993108) manufactured by Pharmacia & Upjohn Co.. 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 11, 1999. Regulation: 8.