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    EU Manufacturer 🇺🇸 United States Active

    Illumina, Inc.

    SRN: US-MF-000013476 · 5200 Illumina Way, CA 92122 San Diego, United States
    View on EUDAMED
    Basic UDI-DIs
    12
    Total Devices
    21
    On Market
    21
    Off Market
    0
    Certificates
    0
    Valid
    0
    Expiring < 6mo
    0
    Countries
    31

    Basic Information

    Address
    5200 Illumina Way, CA 92122 San Diego, United States
    Email
    [email protected]
    Website
    www.illumina.com

    Regulatory Overview

    Regulation
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    Eu Ivdr 11
    Eu Ivdd 1
    Classification
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    Eu Ivd Class A 10
    Eu Ivd Class C 1
    Eu Ivd General 1
    Device Types
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    Certificate Health

    No certificates registered for this manufacturer.

    Market Presence

    Devices from this manufacturer are available in 31 countries across Europe.

    🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

    Device Portfolio

    Name
    Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (16 samples)
    Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (16 samples)
    Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (96 Samples)
    Local Run Manager DNA Generate FASTQ Dx Module for NextSeq 550Dx
    Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx
    Local Run Manager VeriSeq™ NIPT module
    MiSeq™Dx Instrument
    MiSeq™Dx Reagent Kit v3
    MiSeq™Dx Reagent Kit v3 Micro
    NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles)
    NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles)
    NextSeq™ 550Dx Instrument
    NovaSeq 6000Dx S2 Reagent v1.5 Kit (300 cycles)
    NovaSeq™ 6000Dx Instrument
    NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles)
    TruSight™ Oncology Comprehensive (EU) kit
    VeriSeq™ NIPT Sample Preparation Kit (24 samples)
    VeriSeq™ NIPT Sample Preparation Kit (48 samples)
    VeriSeq™ NIPT Sample Preparation Kit (96 samples)
    VeriSeq™ NIPT Workflow Manager v2
    llumina® DNA Prep with Enrichment Dx with UD Indexes Set A (96 samples)