FDA.reportPublic FDA data

De Novo DEN030004

Device
WEST NILE VIRUS IGM CAPTURE ELISA
Contact
helen jennings
De Novo number
DEN030004
Product code
NOP
Regulation
866.3940
Classification name
elisa, antibody, west nile virus
Decision
granted (DENG)
Decision date
2003-07-08
Date received
2003-07-03
Classification advisory
Microbiology
Review advisory
Microbiology
Type
Post-NSE

Current FDA Classification#

Product code
NOP
Device name
Elisa, Antibody, West Nile Virus
Medical specialty
Microbiology
Device class
2
Regulation
866.3940
Implant
N
Life sustain/support
N