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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 device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples
De Novo Number DEN200040
Device Name OMNIgene GUT Dx
Requester
dna genotek inc.
3000 - 500 palladium drive
ottawa,  CA k2v 1c2
Contact austin udocor
Regulation Number866.2952
Classification Product Code
QPO  
Date Received06/15/2020
Decision Date 11/03/2021
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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