Product code QDI— Medical Genetics

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

Classification name: Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies
Device class: Class 2
Regulation: 21 CFR 864.1880
Advisory panel: Medical Genetics
Total cleared: 1
First cleared: 2018-12-21
Most recent: 2018-12-21

Market context for product code QDI

FDA has cleared 1 device under product code QDI, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QDI

Cytocell, Ltd.1 clearance

Recent clearances under product code QDI

DEN170070 — 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 KitCytocell, Ltd.·2018-12-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.