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January 13, 2021
Company: Ortho-Clinical Diagnostics, Inc. Date of Enforcement Report: 1/13/2021 Class II PRODUCT enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN – Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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