EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA

EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA is an FDA 510(k)-cleared medical device (K921628) manufactured by Incstar Corp.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 13, 1992. Regulation: 8.