BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Illumina, Inc.

    Reg #: 3003218906 · FEI: 3003218906 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    32
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    Illumina, Inc.
    Registration Number
    3003218906
    FEI Number
    3003218906
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5200 Illumina Way
    City
    San Diego
    State
    CA
    ZIP
    92122
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132750
    PMA Number
    P230011

    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
    System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection PFR
    Dna And Rna Oncology Controls SCU
    High Throughput Dna Sequence Analyzer PFF
    Reagents For Molecular Diagnostic Test Systems PFT
    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System PQP

    Proprietary Names

    Local Run Manager CF Clinical Sequencing Analysis Module Local Run Manager CF Clinical Seq 2 Micro Analysis Module Local Run Manager CF 139-Variant 2 Micro Analysis Module Local Run Manager CF 139 Variant Analysis Module TruSight™ Oncology DNA Control TruSight™ Oncology RNA Control NextSeq™ 550Dx Instrument NovaSeq™ 6000Dx Instrument Illumina DRAGEN Server for NextSeq 550Dx NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles) DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NovaSeq 6000Dx Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (16 samples) TruSeq™ Custom Amplicon Kit Dx- FFPE NovaSeq™ 6000Dx S2 Buffer Cartridge NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles) Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (96 samples) TruSight™ Cystic Fibrosis Library Prep NovaSeq™ 6000Dx Library Tube, 24 pack NovaSeq™ 6000Dx Library Tube MiSeq™Dx Reagent Kit V3 Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (16 samples) MiSeq™Dx Reagent Kit V3 Micro NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (96 samples) TruSeq™ Custom Amplicon Kit Dx NovaSeq™ 6000Dx S4 Buffer Cartridge DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx TruSight Oncology Comprehensive MiSeq™Dx China MiSeq™Dx

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility