Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit

Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection

Meridian Bioscience, Inc.

The following data is part of a De Novo classification by Meridian Bioscience, Inc. with the FDA for Alethia Cmv Dna Amplification Assay, Alethia Cmv External Control Kit.

Pre-market Notification Details

DeNovo IDDEN180040
Device Name:Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
ClassificationQualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection
Applicant Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati,  OH  45244
ContactJack Rogers
Product CodeQDZ  
CFR Regulation Number866.3181 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardMicrobiology
Classification AdvisoryMicrobiology
TypeDirect
Date Received2018-07-30
Decision Date2018-11-30
Reclassification Order:Reclassification Order

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