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 ID: DEN200040
• Device Name: OMNIgene GUT Dx
• Classification: Device 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
• Contact: Austin Udocor
• Product Code: QPO
• CFR Regulation Number: 866.2952 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device 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 Board: Microbiology
• Classification Advisory: Microbiology
• Type: Direct
• Date Received: 2020-06-15
• Decision Date: 2021-11-03
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00627595000774	DEN200040	000