BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (96 samples)

    Reg #: 3003218906 · FEI: 3003218906 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    Establishment Types
    3
    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

    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
    Reagents For Molecular Diagnostic Test Systems PFT

    Proprietary Names

    Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (96 samples) TruSeq™ Custom Amplicon Kit Dx- FFPE TruSight™ Cystic Fibrosis Library Prep NovaSeq™ 6000Dx Library Tube, 24 pack Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (16 samples) NovaSeq™ 6000Dx S4 Buffer Cartridge Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (96 samples) NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles) Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq 550Dx NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles) NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) MiSeq™Dx Reagent Kit V3 NovaSeq™ 6000Dx Library Tube Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx 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 B (16 samples) TruSeq™ Custom Amplicon Kit Dx DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NovaSeq 6000Dx NovaSeq™ 6000Dx S2 Buffer Cartridge

    Establishment Types

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