BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VITEK® 2 AST-GP67

    DI: 03573026530648 · Model: VITEK® 2 AST-GP67 · BIOMERIEUX , INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VITEK® 2 AST-GP67
    Primary DI
    03573026530648
    Version / Model
    VITEK® 2 AST-GP67
    Company Name
    BIOMERIEUX , INC.
    Labeler DUNS
    086785110
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-09
    Public Version
    4
    Public Version Date
    2022-05-11
    Public Version Status
    Update
    Public Device Record Key
    13c9f42c-79f0-4dce-9555-7232d0436c53

    Device Description

    VITEK ® 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae

    Device Characteristics

    Single Use
    Yes
    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
    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
    LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

    GMDN Terms

    Code Name
    58605 General-microorganism antimicrobial susceptibility culture medium IVD

    Identifiers

    Type ID
    Package 03573026242060
    Primary 03573026530648

    Premarket Submissions

    Submission Number Supplement Number
    K032399 000
    K032738 000
    K032766 000
    K050976 000
    K053097 000
    K072668 000
    K072695 000
    K080201 000
    N50510 084
    N50510 085
    N50510 102
    N50510 106
    N50510 108
    N50510 111
    N50510 113
    N50510 116
    N50510 117

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius