BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Illumina, Inc. Hayward

    Reg #: 3006296346 · FEI: 3005095756 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Illumina, Inc. Hayward
    Registration Number
    3006296346
    FEI Number
    3005095756
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    25841 Industrial Blvd
    City
    Hayward
    State
    CA
    ZIP
    94545
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN130011

    Owner / Operator

    Firm Name
    Illumina, Inc.
    Operator Number
    10030352
    Address
    5200 Illumina Way
    City
    San Diego
    State
    CA
    Postal Code
    92122
    Country
    US
    Correspondent
    Karen Gutekunst

    Products

    Device Name Product Code
    High Throughput Dna Sequence Analyzer PFF

    Proprietary Names

    MiSeq™Dx China MiSeq™Dx NextSeq™ 550Dx Instrument NovaSeq™ 6000Dx Instrument Illumina DRAGEN Server for NextSeq 550Dx

    Establishment Types

    Manufacture Medical Device