RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM

RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM is an FDA 510(k)-cleared medical device (K911444) manufactured by Wampole Laboratories. 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 29, 1991. Regulation: 8.