FDA.reportPublic FDA data

De Novo DEN180069

Device
ZIKV Detect 2.0 IgM Capture ELISA
Contact
estela raychaudhuri
De Novo number
DEN180069
Product code
QFO
Regulation
866.3935
Classification name
zika virus serological reagents
Decision
granted (DENG)
Decision date
2019-05-23
Date received
2018-12-26
Classification advisory
Microbiology
Review advisory
Microbiology
Type
Direct

Current FDA Classification#

Product code
QFO
Device name
Zika Virus Serological Reagents
Medical specialty
Microbiology
Device class
2
Regulation
866.3935
Implant
N
Life sustain/support
N