FDA.reportPublic FDA data

De Novo DEN130003

Device
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)
Contact
lubna syed
De Novo number
DEN130003
Product code
PCH
Regulation
866.3990
Classification name
gastrointestinal pathogen panel multiplex nucleic acid-based assay system
Decision
granted (DENG)
Decision date
2013-01-14
Date received
2013-01-11
Classification advisory
Microbiology
Review advisory
Microbiology
Type
Post-NSE

Current FDA Classification#

Product code
PCH
Device name
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Medical specialty
Microbiology
Device class
2
Regulation
866.3990
Implant
N
Life sustain/support
N