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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name qualitative cytomegalovirus nucleic acid-based detection device for congenital cytomegalovirus infection
De Novo Number DEN180040
Device Name Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
Meridian Bioscience, Inc.
3471 river hills drive
cincinnati,  OH  45244
Contact jack rogers
Regulation Number866.3181
Classification Product Code
Date Received07/30/2018
Decision Date 11/30/2018
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct