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 K

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

Cytocell Ltd

The following data is part of a De Novo classification by Cytocell Ltd with the FDA for 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 K.

Pre-market Notification Details

DeNovo IDDEN170070
Device Name: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 K
ClassificationFish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies
Applicant Cytocell Ltd 3-4 Technopark, Newmarket Road Cambridge,  GB Cb5 8pb
ContactXavier Baker
Product CodeQDI  
CFR Regulation Number864.1880 [🔎]
DecisionGranted (DENG)
Review Advisory BoardMolecular Genetics
Classification AdvisoryMolecular Genetics
TypeDirect
Date Received2017-09-29
Decision Date2018-12-21
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05055844901605 DEN170070 000
05055844901599 DEN170070 000
05055844901582 DEN170070 000
05055844901575 DEN170070 000
05055844901568 DEN170070 000
05055844901551 DEN170070 000
05055844901544 DEN170070 000
05055844901520 DEN170070 000

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