COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS

COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS is an FDA 510(k)-cleared medical device (K912489) manufactured by Immuno Concepts, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 23, 1991. Regulation: 8.