FDA.reportPublic FDA data

De Novo DEN200040

Device
OMNIgene GUT Dx
Contact
austin udocor
De Novo number
DEN200040
Product code
QPO
Regulation
866.2952
Classification name
device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples
Decision
granted (DENG)
Decision date
2021-11-03
Date received
2020-06-15
Classification advisory
Microbiology
Review advisory
Microbiology
Type
Direct

Current FDA Classification#

Product code
QPO
Device name
Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
Medical specialty
Microbiology
Device class
2
Regulation
866.2952
Implant
N
Life sustain/support
N