De Novo DEN170080

Device

Adaptive Biotechnologies clonoSEQ Assay

Contact

b. melina cimler

De Novo number

DEN170080

Product code

QDC

Regulation

866.6100

Classification name

dna-based test for minimal residual disease for hematologic malignancies

Decision

granted (DENG)

Decision date

2018-09-28

Date received

2017-09-29

Classification advisory

Pathology

Review advisory

Pathology

Type

Direct