BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    CYTOCELL LIMITED

    Reg #: 9710378 · FEI: 3002646096 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    31
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    CYTOCELL LIMITED
    Registration Number
    9710378
    FEI Number
    3002646096
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Oxford Gene Technology, 418 Cambridge Science Park, Milton Road
    City
    CAMBRIDGE Cambridgeshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    DEN240067

    Owner / Operator

    Firm Name
    Oxford Gene Technology (IP) Limited
    Operator Number
    9026291
    Address
    Oxford Gene Technology (IP) Limited, Unit 5, 4A Technology Drive,
    City
    Kidlington
    State
    Oxfordshire
    Postal Code
    OX5 1GN
    Country
    GB
    Correspondent
    Faidra Partheniou

    US Agent

    Business Name
    OXFORD GENE TECHNOLOGY, INC.
    Contact Name
    Mike Ornelas
    Address
    520 White Plains Rd Ste 500
    City
    N Tarrytown
    State
    NY
    ZIP
    10591
    Country
    US
    Email
    [email protected]
    Phone
    732 2079524

    Products

    Device Name Product Code
    Revumenib Eligibility Detection System SFS
    Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies QDI
    Reagents, Specific, Analyte MVU
    General Purpose Reagent PPM

    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*) 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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device