FDA.reportPublic FDA data

De Novo DEN120008

Device
STRATIFY JCV(TM) ANTIBODY
Contact
tara viviani
De Novo number
DEN120008
Product code
OYP
Regulation
866.3336
Classification name
anti-jcv antibody detection assay
Decision
granted (DENG)
Decision date
2012-01-20
Date received
2012-01-06
Classification advisory
Microbiology
Review advisory
Microbiology
Type
Post-NSE

Current FDA Classification#

Product code
OYP
Device name
Anti-Jcv Antibody Detection Assay
Medical specialty
Microbiology
Device class
2
Regulation
866.3336
Implant
N
Life sustain/support
N