De Novo DEN070004

Device

XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065

Contact

russel k enns, ph.d.

De Novo number

DEN070004

Product code

OAI

Regulation

866.3225

Classification name

assay, enterovirus nucleic acid

Decision

granted (DENG)

Decision date

2007-03-16

Date received

2007-03-12

Classification advisory

Microbiology

Review advisory

Microbiology

Type

Post-NSE