De Novo DEN170070

Device

MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit

Contact

xavier baker

De Novo number

DEN170070

Product code

QDI

Regulation

864.1880

Classification name

fish based detection of chromosomal abnormalities from patients with hematologic malignancies

Decision

granted (DENG)

Decision date

2018-12-21

Date received

2017-09-29

Classification advisory

Molecular Genetics

Review advisory

Molecular Genetics

Type

Direct