ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS

ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS is an FDA 510(k)-cleared medical device (K931443) manufactured by Ortho Diagnostic Systems, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 4, 1993. Regulation: 8.