
Ortho Diagnostic Systems, Inc.
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ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO. is an FDA 510(k)-cleared medical device (K872541) 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 May 12, 1988. Regulation: 8.

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