VIRGO(TM) RUBELLA IGG ELISA

VIRGO(TM) RUBELLA IGG ELISA is an FDA 510(k)-cleared medical device (K873088) manufactured by Electro-Nucleonics Laboratories, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 8, 1987. Regulation: 8.