BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OXFORD GENE TECHNOLOGY, INC.

    Reg #: 3011279282 · FEI: 3011279282 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    OXFORD GENE TECHNOLOGY, INC.
    Registration Number
    3011279282
    FEI Number
    3011279282
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    520 White Plains Rd Ste 500
    City
    North Tarrytown
    State
    NY
    ZIP
    10591
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN170070

    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

    Products

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

    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)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198