De Novo DEN200043

Device

FilmArray Global Fever Panel

Contact

cynthia phillips

De Novo number

DEN200043

Product code

QMV

Regulation

866.3966

Classification name

device to detect and identify selected microbial agents that cause acute febrile illness

Decision

granted (DENG)

Decision date

2020-11-20

Date received

2020-06-26

Classification advisory

Microbiology

Review advisory

Microbiology

Type

Direct