De Novo DEN140005

Device

LYRA DIRECT STREP ASSAY

Contact

ronald h lollar

De Novo number

DEN140005

Product code

PGX

Regulation

866.2680

Classification name

groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system

Decision

granted (DENG)

Decision date

2014-04-16

Date received

2014-03-25

Classification advisory

Microbiology

Review advisory

Microbiology

Type

Post-NSE