OMNIgene GUT Dx

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

DNA Genotek Inc.

The following data is part of a De Novo classification by Dna Genotek Inc. with the FDA for Omnigene Gut Dx.

Pre-market Notification Details

DeNovo IDDEN200040
Device Name:OMNIgene GUT Dx
ClassificationDevice To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
Applicant DNA Genotek Inc. 3000 - 500 Palladium Drive Ottawa,  CA K2v 1c2
ContactAustin Udocor
Product CodeQPO  
CFR Regulation Number866.2952 [🔎]
DecisionGranted (DENG)
510(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 Received2020-06-15
Decision Date2021-11-03
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00627595000774 DEN200040 000

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