FDA.reportPublic FDA data

De Novo DEN200070

Device
Simple 2 Test
Contact
karen walsh
De Novo number
DEN200070
Product code
QYA
Regulation
866.3385
Classification name
system for detection of nucleic acid from non-viral microorganism(s) causing stis using specimens collected at home
Decision
granted (DENG)
Decision date
2023-11-15
Date received
2020-11-16
Classification advisory
Microbiology
Review advisory
Microbiology
Type
Direct

Current FDA Classification#

Product code
QYA
Device name
System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
Medical specialty
Microbiology
Device class
2
Regulation
866.3385
Implant
N
Life sustain/support
N