FDA.reportPublic FDA data

De Novo DEN240029

Device
Healgen Rapid Check COVID-19/Flu A&B Antigen Test
Contact
bingliang fang
De Novo number
DEN240029
Product code
SCA
Regulation
866.3987
Classification name
multi-analyte respiratory virus antigen detection test
Decision
granted (DENG)
Decision date
2024-10-07
Date received
2024-06-07
Classification advisory
Microbiology
Review advisory
Microbiology
Type
Direct

Current FDA Classification#

Product code
SCA
Device name
Multi-Analyte Respiratory Virus Antigen Detection Test
Medical specialty
Microbiology
Device class
2
Regulation
866.3987
Implant
N
Life sustain/support
N