COPALIS MULTIPLEX EBV ANTIBODY ASSAY

COPALIS MULTIPLEX EBV ANTIBODY ASSAY is an FDA 510(k)-cleared medical device (K991660) manufactured by DiaSorin, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 3, 1999. Regulation: 8.