BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MiSeq™ Dx (China)

    DI: 00816270020699 · Model: 20014053 · ILLUMINA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MiSeq™ Dx (China)
    Primary DI
    00816270020699
    Version / Model
    20014053
    Catalog Number
    20014053
    Company Name
    ILLUMINA, INC.
    Labeler DUNS
    033305264
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-25
    Public Version
    1
    Public Version Date
    2022-05-03
    Public Version Status
    New
    Public Device Record Key
    05b3aea9-ac22-425c-88e5-e8608e66b8cc

    Device Description

    The Illumina MiSeqDx is intended for targeted sequencing of human DNA using Illumina sequencing consumables and libraries prepared from human genomic DNA extracted from peripheral whole blood or formalin-fixed, paraffin-embedded (FFPE) tissue. Libraries are prepared by amplifying targets and adding sample indexes and capture sequences. Sample 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 as they are incorporated into growing DNA strands. The Real-Time Analysis (RTA) software performs image analysis and base calling, and assigns a quality score to each base for each sequencing cycle. The MiSeqDx instrument is not intended for whole genome or de novo sequencing. The MiSeqDx instrument is to be used with registered and listed, cleared, or approved IVD reagents and analytical software.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    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 00816270020699