
Amico Laboratories, Inc.
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AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST is an FDA 510(k)-cleared medical device (K911362) manufactured by Amico Laboratories, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 6, 1991. Regulation: 8.

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