BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    xTAG® Cystic Fibrosis (CFTR) 39 kit v2

    DI: 00840487100141 · Model: I027C0231 · Luminex Molecular Diagnostics, Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    xTAG® Cystic Fibrosis (CFTR) 39 kit v2
    Primary DI
    00840487100141
    Version / Model
    I027C0231
    Catalog Number
    I027C0231
    Company Name
    Luminex Molecular Diagnostics, Inc
    Labeler DUNS
    255371916
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    4
    Public Version Date
    2019-10-28
    Public Version Status
    Update
    Public Device Record Key
    9943eb4c-1c23-4501-9e07-b92f24a61988

    Device Description

    The xTAG® Cystic Fibrosis 39 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens.

    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
    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
    NUA System, cystic fibrosis transmembrane conductance regulator, gene mutation detection

    GMDN Terms

    Code Name
    59365 Cystic fibrosis IVD, kit, multiplex

    Identifiers

    Type ID
    Primary 00840487100141

    Customer Contacts

    Phone
    +1(877)785-2323
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 6 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    -25 – -15 Degrees Celsius