FDA.reportPublic FDA data

De Novo DEN180032

Device
Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
Contact
sujith kallur
De Novo number
DEN180032
Product code
QGN
Regulation
866.3230
Classification name
lateral flow immunochromatography assay for host infection biomarkers
Decision
granted (DENG)
Decision date
2019-05-23
Date received
2018-06-29
Classification advisory
Microbiology
Review advisory
Microbiology
Type
Direct

Current FDA Classification#

Product code
QGN
Device name
Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
Medical specialty
Microbiology
Device class
2
Regulation
866.3230
Implant
N
Life sustain/support
N