BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AFFYMETRIX, INC.

    Reg #: 3003314809 · FEI: 3003314809 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    AFFYMETRIX, INC.
    Registration Number
    3003314809
    FEI Number
    3003314809
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3450 Central Expy
    City
    Santa Clara
    State
    CA
    ZIP
    95051
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN130018

    Owner / Operator

    Firm Name
    Life Technologies
    Operator Number
    9066102
    Address
    5781 Van Allen Way, --
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Jody M Schulz

    Products

    Device Name Product Code
    System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection PFX
    Instrumentation For Clinical Multiplex Test Systems NSU

    Proprietary Names

    CytoScan® Dx Assay Concerto Imager GeneChip System 3000Dx v.2

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Device in the United States for Export Only