BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CytoCell Microdeletion (LPU*)

    Reg #: 3011279282 · FEI: 3011279282 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    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

    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
    Reagents, Specific, Analyte MVU

    Proprietary Names

    CytoCell Microdeletion (LPU*) CytoCell Enumeration (LPE*) Analyte Specific Reagents with the following brand names: myProbes (MPA*, MPD*, MPH*, MPP*) CytoCell Haematology (LPH*) CytoCell Telomere (LPT*) CytoCell Pathology (LPS*, LPD*)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198