De Novo DEN200044

Device

Eonis SCID-SMA Kit

Contact

casey fox

De Novo number

DEN200044

Product code

QUE

Regulation

866.5980

Classification name

spinal muscular atrophy newborn screening test system

Decision

granted (DENG)

Decision date

2022-11-09

Date received

2020-07-08

Classification advisory

Immunology

Review advisory

Molecular Genetics

Type

Direct