BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Xpert BCR-ABL Ultra

    DI: 07332940007102 · Model: GXBCRABL-US-10 · CEPHEID
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Xpert BCR-ABL Ultra
    Primary DI
    07332940007102
    Version / Model
    GXBCRABL-US-10
    Catalog Number
    GXBCRABL-US-10
    Company Name
    CEPHEID
    Labeler DUNS
    956711444
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-25
    Public Version
    2
    Public Version Date
    2020-10-06
    Public Version Status
    Update
    Public Device Record Key
    5b24dea1-190d-4e6c-87a4-6dd2c5474875

    Device Description

    Xpert BCR-ABL Ultra test; 10 test kit

    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
    OYX Bcr/Abl1 Monitoring Test

    GMDN Terms

    Code Name
    44431 Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 07332940007102

    Customer Contacts

    Phone
    1 888 838 3222
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K190076 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius