IS EBV-EBNA-1 IGG ELISA TEST SYSTEM

IS EBV-EBNA-1 IGG ELISA TEST SYSTEM is an FDA 510(k)-cleared medical device (K981829) manufactured by Diamedix Corp.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 15, 1999. Regulation: 8.