ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA

ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA is an FDA 510(k)-cleared medical device (K953826) manufactured by Pyramid Biological 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 December 13, 1995. Regulation: 8.