BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VITEK® 2 AST-GP68

    DI: 03573026530792 · Model: VITEK® 2 AST-GP68 · BIOMERIEUX , INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VITEK® 2 AST-GP68
    Primary DI
    03573026530792
    Version / Model
    VITEK® 2 AST-GP68
    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
    7e1db16f-a010-4696-96b0-6bf7dfcee545

    Device Description

    VITEK ® 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine susceptibility of Staphylococcus spp., Enterococcus spp., & 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 03573026245573
    Primary 03573026530792

    Premarket Submissions

    Submission Number Supplement Number
    K020871 000
    K031410 000
    K031865 000
    K051849 000
    K053186 000
    K063597 000
    K063623 000
    K083383 000
    N50510 131
    N50510 132
    N50510 133
    N50510 135
    N50510 136
    N50510 137
    N50510 138
    N50510 139
    N50510 145

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius