Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011279282

FEI Number

3011279282

Entity Name

OXFORD GENE TECHNOLOGY, INC.

City/State/Country

North Tarrytown, NY, US

Establishment Address

520 White Plains Rd Ste 500, North Tarrytown, NY 10591, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

DEN240067

PMA Number

N/A

All Registered Proprietary Names

CytoCell DAPI Antifade Counterstain FS (DFS 500L, DFS 10ML) CytoCell 8 Square Template Slides (PCN 008) CytoCell Rubber Solution Glue (PCA 005) CytoCell DAPI Antifade Counterstain SS (DSS 500L) CytoCell Slide Surface Thermometer (PCN 002) CytoCell Hybridisation Solution B (HB 500L, HB 1000L) CytoCell 24 Square Template Slides (PCN 007) CytoCell Mounting Medium (PCN 003) CytoCell 20x SSC Buffer (PCA 003) CytoCell Hybridisation Chamber (PCN 004) CytoCell Porcelain Wash Jars (PCN 009) CytoCell Hybridisation Solution I (HI 1000L) CytoCell DAPI Antifade Counterstain ES (DES 500L, DES 1000L, DES 10ML) CytoCell Tissue Pretreatment Kit (LPS 100) CytoCell 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*) 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 CytoCell KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2012-01-05
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2001-06-14
QDI	Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies	Medical Genetics	Class 2	864.1880	2019-01-09
SFS	Revumenib Eligibility Detection System	Hematology	Class 2	864.1885	2025-09-22

Official Correspondent

Faidra Partheniou

US Agent Details

No US Agent registered (Local establishment).

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
9710378	CYTOCELL LIMITED	CAMBRIDGE Cambridgeshire, GB

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011279282. Last updated year: 2026. Please use registration number 3011279282 when referencing this establishment in official correspondence.