FDA.reportPublic FDA data

De Novo DEN070013

Device
ID-TAG RESPIRATORY VIRAL PANEL
Contact
gloria lee
De Novo number
DEN070013
Product code
OCC
Regulation
866.3980
Classification name
respiratory virus panel nucleic acid assay system
Decision
granted (DENG)
Decision date
2008-01-03
Date received
2007-12-04
Classification advisory
Microbiology
Review advisory
Microbiology
Type
Post-NSE

Current FDA Classification#

Product code
OCC
Device name
Respiratory Virus Panel Nucleic Acid Assay System
Medical specialty
Microbiology
Device class
2
Regulation
866.3980
Implant
N
Life sustain/support
N