Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710378

FEI Number

3002646096

Entity Name

CYTOCELL LIMITED

City/State/Country

CAMBRIDGE Cambridgeshire, GB

Establishment Address

Oxford Gene Technology, 418 Cambridge Science Park, Milton Road, CAMBRIDGE Cambridgeshire CB4 0PZ, GB

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Oxford Gene Technology (IP) Limited (Owner Number: 9026291)

Owner / Operator Contact Address

Oxford Gene Technology (IP) Limited, Unit 5, 4A Technology Drive,, Kidlington, GB-OXF OX5 1GN, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CytoCell KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) USA-LPH013 CytoCell MLL (KMT2A) Breakapart FISH Probe Kit USA-LPH017 CytoCell P53 (TP53) Deletion FISH Probe Kit USA-LPH025 CytoCell Del(7q) Deletion FISH Probe Kit USA-LPH022 CytoCell CBF? (CBFB)/MYH11 Translocation, Dual Fusion FISH Probe Kit USA-LPH026 CytoCell AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit USA-LPH036 CytoCell EVI1 (MECOM) Breakapart FISH Probe Kit USA-LPH024 CytoCell Del(5q) Deletion FISH Probe Kit USA-LPH020 CytoCell Del(20q) Deletion FISH Probe Kit myProbes (MPA*, MPD*, MPH*, MPP*) CytoCell Pathology (LPS*, LPD*) CytoCell Enumeration (LPE*) Analyte Specific Reagents with the following brand names: CytoCell Telomere (LPT*) CytoCell Haematology (LPH*) CytoCell Microdeletion (LPU*)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SFS	Revumenib Eligibility Detection System	Hematology	Class 2	864.1885	2025-09-22
QDI	Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies	Medical Genetics	Class 2	864.1880	2019-01-09
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2001-06-14

Official Correspondent

Faidra Partheniou

US Agent Details

Mike Ornelas Business: OXFORD GENE TECHNOLOGY, INC. Email: mike.ornelas@ogt.com Phone: (732) 2079524

Related Public Records

Same Entity

Oxford Gene Technology (IP) Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011279282	OXFORD GENE TECHNOLOGY, INC.	North Tarrytown, NY, US

Similar Registrations

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3011279282	OXFORD GENE TECHNOLOGY, INC.	North Tarrytown, NY, US
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1124976	SUPERTECHS, INC.	Gaithersburg, MD, US
3011873748	AUGUREX LIFE SCIENCES CORP	Vancouver British Columbia, CA
3013059683	ATSI Logistics Center ApS	GLOSTRUP Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710378. Last updated year: 2026. Please use registration number 9710378 when referencing this establishment in official correspondence.