FDA.reportPublic FDA data

De Novo DEN180047

Device
Aptima Mycoplasma genitalium Assay
Contact
jeffrey hergesheimer
De Novo number
DEN180047
Product code
QEP
Regulation
866.3393
Classification name
nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
Decision
granted (DENG)
Decision date
2019-01-23
Date received
2018-08-31
Classification advisory
Microbiology
Review advisory
Microbiology
Type
Direct

Current FDA Classification#

Product code
QEP
Device name
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Medical specialty
Microbiology
Device class
2
Regulation
866.3393
Implant
N
Life sustain/support
N