De Novo DEN110012

Device

APTIMA TRICHOMONAS VAGINALIS ASSAY

Contact

maria carmelita s baluyot

De Novo number

DEN110012

Product code

OUY

Regulation

866.3860

Classification name

trichomonas vaginalis nucleic acid amplification test system

Decision

granted (DENG)

Decision date

2011-04-19

Date received

2011-04-13

Classification advisory

Immunology

Review advisory

Microbiology

Type

Post-NSE