BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Xpert EV

    DI: 07332940000097 · Model: GXEV-100N-10 · CEPHEID
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Xpert EV
    Primary DI
    07332940000097
    Version / Model
    GXEV-100N-10
    Catalog Number
    GXEV-100N-10
    Company Name
    CEPHEID
    Labeler DUNS
    956711444
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-29
    Public Version
    5
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    79a234fa-e00b-408f-9378-2c85b16c4652

    Device Description

    Xpert EV kit; 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
    OAI Assay, Enterovirus Nucleic Acid

    GMDN Terms

    Code Name
    61043 Multiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 07332940000097

    Customer Contacts

    Phone
    1 888 838 3222
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    DEN070004 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 28 Degrees Celsius