INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY

INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY is an FDA 510(k)-cleared medical device (K955360) manufactured by Incstar 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 July 21, 1996. Regulation: 8.