FDA.reportPublic FDA data

De Novo DEN200072

Device
Lumipulse G ß-Amyloid Ratio (1-42/1-40)
Contact
stacey dolan
De Novo number
DEN200072
Product code
QSE
Regulation
866.5840
Classification name
alzheimer’s disease pathology assessment test
Decision
granted (DENG)
Decision date
2022-05-04
Date received
2020-11-20
Classification advisory
Immunology
Review advisory
Immunology
Type
Direct

Current FDA Classification#

Product code
QSE
Device name
Alzheimer’S Disease Pathology Assessment Test
Medical specialty
Immunology
Device class
2
Regulation
866.5840
Implant
N
Life sustain/support
N