FDA.reportPublic FDA data

De Novo DEN150009

Device
B.R.A.H.M.S PCT sensitive KRYPTOR
Contact
bernhard ciommer
De Novo number
DEN150009
Product code
PMT
Regulation
866.3215
Classification name
device to detect and measure procalcitonin (pct) in human clinical specimens
Decision
granted (DENG)
Decision date
2016-02-20
Date received
2015-03-04
Classification advisory
Microbiology
Review advisory
Microbiology
Type
Direct

Current FDA Classification#

Product code
PMT
Device name
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
Medical specialty
Microbiology
Device class
2
Regulation
866.3215
Implant
N
Life sustain/support
N