Cytocell Ltd

FDA Filings

This page includes the latest FDA filings for Cytocell Ltd. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate
Cytocell Ltd
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 K2018-12-21

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Cytocell Aquarius
CYTOCELL LIMITED2019-02-28
Cytocell Aquarius
CYTOCELL LIMITED2019-02-28
Cytocell Aquarius
CYTOCELL LIMITED2019-02-28
Cytocell Aquarius
CYTOCELL LIMITED2019-02-28
Cytocell Aquarius
CYTOCELL LIMITED2019-02-28
Cytocell Aquarius
CYTOCELL LIMITED2019-02-28
Cytocell Aquarius
CYTOCELL LIMITED2019-02-28
Cytocell Aquarius
CYTOCELL LIMITED2019-02-28

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