BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NextSeq 550Dx Sequencing System

    DI: 00816270020125 · Model: 20005715 · ILLUMINA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NextSeq 550Dx Sequencing System
    Primary DI
    00816270020125
    Version / Model
    20005715
    Catalog Number
    20005715
    Company Name
    ILLUMINA, INC.
    Labeler DUNS
    033305264
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-09
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    7c8c633e-6bdf-4389-85d6-730362d337ba

    Device Description

    The Illumina NextSeq 550Dx instrument is intended for sequencing DNA libraries prepared by adding sample indices and capture sequences to amplified targets. These libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases incorporated into growing DNA strands. Instrument software performs image analysis and base calling, assigning a quality score to each base for each sequencing cycle. When primary analysis finishes, secondary analysis processes base calls on the instrument. The NextSeq 550Dx instrument uses different secondary analysis modules depending on the workflow. For the germline or somatic variant calling modules, data processing includes de-multiplexing, FASTQ file generation, alignment, variant calling, and generation of variant call format (VCF) files containing information regarding variants found at specific positions in a reference genome.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PFF High Throughput Dna Sequence Analyzer

    GMDN Terms

    Code Name
    61957 Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)

    Identifiers

    Type ID
    Primary 00816270020125