BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Local Run Manager CF Clinical Seq 2 Micro Analysis Module

    Reg #: 3003218906 · FEI: 3003218906 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Illumina, Inc.
    Registration Number
    3003218906
    FEI Number
    3003218906
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5200 Illumina Way
    City
    San Diego
    State
    CA
    ZIP
    92122
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132750

    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
    System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection PFS

    Proprietary Names

    Local Run Manager CF Clinical Seq 2 Micro Analysis Module Local Run Manager CF Clinical Sequencing Analysis Module

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device