FDA.reportPublic FDA data

De Novo DEN120013

Device
PORTRAIT ANALYZER
Contact
larry rea
De Novo number
DEN120013
Product code
OMN
Regulation
866.2660
Classification name
c. difficile nucleic acid amplification test assay
Decision
granted (DENG)
Decision date
2012-04-30
Date received
2012-03-02
Classification advisory
Microbiology
Review advisory
Microbiology
Type
Post-NSE

Current FDA Classification#

Product code
OMN
Device name
C. Difficile Nucleic Acid Amplification Test Assay
Medical specialty
Microbiology
Device class
1
Regulation
866.2660
Implant
N
Life sustain/support
N