De Novo DEN190023

Device

AmplideX Fragile X Dx & Carrier Screen Kit

Contact

bernard andruss

De Novo number

DEN190023

Product code

OYV

Regulation

866.5970

Classification name

inherited nucleotide repeat disorder dna test

Decision

granted (DENG)

Decision date

2020-02-21

Date received

2019-04-18

Classification advisory

Immunology

Review advisory

Molecular Genetics

Type

Direct