FDA.reportPublic FDA data

De Novo DEN170029

Device
PrimeStore MTM
Contact
jeff fischer
De Novo number
DEN170029
Product code
QBD
Regulation
866.2950
Classification name
microbial nucleic acid storage and stabilization device
Decision
granted (DENG)
Decision date
2018-03-19
Date received
2017-05-24
Classification advisory
Microbiology
Review advisory
Microbiology
Type
Direct

Current FDA Classification#

Product code
QBD
Device name
Microbial Nucleic Acid Storage And Stabilization Device
Medical specialty
Microbiology
Device class
2
Regulation
866.2950
Implant
N
Life sustain/support
N