BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VITEK®2

    DI: 03573026145842 · Model: 27222R · BIOMERIEUX , INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VITEK®2
    Primary DI
    03573026145842
    Version / Model
    27222R
    Company Name
    BIOMERIEUX , INC.
    Labeler DUNS
    086785110
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-14
    Public Version
    4
    Public Version Date
    2019-03-11
    Public Version Status
    Update
    Public Device Record Key
    1c1f7079-5cdf-4643-8d21-20da30eef029

    Device Description

    VITEK®2 XL is an automated system that performs large volumes of bacterial ID & AST testings

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

    GMDN Terms

    Code Name
    56748 Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated

    Identifiers

    Type ID
    Primary 03573026145842

    Premarket Submissions

    Submission Number Supplement Number
    N50510 084

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 50 Degrees Celsius