
Ortho Diagnostic Systems, Inc.
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EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST is an FDA 510(k)-cleared medical device (K911569) 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 June 9, 1991. Regulation: 8.

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