EBV-CHECK(TM) TEST KIT (IGG)

EBV-CHECK(TM) TEST KIT (IGG) is an FDA 510(k)-cleared medical device (K871373) manufactured by Diagnostic Technology, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 24, 1987. Regulation: 8.