De Novo DEN170047

Device

Curetis Unyvero LRT Application

Contact

gail e. radcliffe

De Novo number

DEN170047

Product code

QBH

Regulation

866.3985

Classification name

lower respiratory microbial nucleic acid detection system

Decision

granted (DENG)

Decision date

2018-04-03

Date received

2017-09-11

Classification advisory

Microbiology

Review advisory

Microbiology

Type

Direct