BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    MiSeqDx CF 139 Variant Assay (2 Run)

    DI: 00816270020019 · Model: 15036580 · ILLUMINA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MiSeqDx CF 139 Variant Assay (2 Run)
    Primary DI
    00816270020019
    Version / Model
    15036580
    Catalog Number
    DX-102-1004
    Company Name
    ILLUMINA, INC.
    Labeler DUNS
    033305264
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    3
    Public Version Date
    2023-01-31
    Public Version Status
    Update
    Public Device Record Key
    bfe9f36f-8a87-4272-b154-ebfad24670e7
    Distribution End Date
    2023-01-30

    Device Description

    The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. MiSeqDx Cystic Fibrosis 139 Variant Assay (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15041293 MiSeqDx Cystic Fibrosis 139 Variant Assay 1/5 15041291 MiSeqDx Cystic Fibrosis 139 Variant Assay 1A 15041292 MiSeqDx Cystic Fibrosis 139 Variant Assay 1B 15041294 MiSeqDx Cystic Fibrosis 139 Variant Assay 2/5 15041297 MiSeqDx Cystic Fibrosis 139 Variant Assay 3/5 15041295 MiSeqDx Cystic Fibrosis 139 Variant Assay 3A 15041296 MiSeqDx Cystic Fibrosis 139 Variant Assay 3B 15041298 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 4/5 15041299 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 5/5

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PFR System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

    GMDN Terms

    Code Name
    59365 Cystic fibrosis IVD, kit, multiplex

    Identifiers

    Type ID
    Primary 00816270020019

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    15 – 25 Degrees Celsius