BEUDAMED
    FDA Registration Active 🇺🇸 United States

    USA-LPH025 CytoCell Del(7q) Deletion FISH Probe Kit

    Reg #: 3011279282 · FEI: 3011279282 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OXFORD GENE TECHNOLOGY, INC.
    Registration Number
    3011279282
    FEI Number
    3011279282
    Status
    Active
    Expiry Year
    2025
    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
    Steve Chatters

    Products

    Device Name Product Code
    Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies QDI

    Proprietary Names

    USA-LPH025 CytoCell Del(7q) Deletion FISH Probe Kit USA-LPH022 CytoCell CBF? (CBFB)/MYH11 Translocation, Dual Fusion FISH Probe Kit USA-LPH013 CytoCell MLL (KMT2A) Breakapart FISH Probe Kit USA-LPH024 CytoCell Del(5q) Deletion FISH Probe Kit USA-LPH017 CytoCell P53 (TP53) Deletion FISH Probe Kit USA-LPH020 CytoCell Del(20q) Deletion 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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198