FDA.reportPublic FDA data

De Novo DEN050003

Device
PAXGENE BLOOD RNA SYSTEM
Contact
jing zhang
De Novo number
DEN050003
Product code
NTW
Regulation
866.4070
Classification name
system, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test
Decision
granted (DENG)
Decision date
2005-04-18
Date received
2005-02-28
Classification advisory
Immunology
Review advisory
Pathology
Type
Post-NSE

Current FDA Classification#

Product code
NTW
Device name
System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
Medical specialty
Immunology
Device class
2
Regulation
866.4070
Implant
N
Life sustain/support
N