BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    VITEK® 2 AST-YS05

    DI: 03573026529758 · Model: VITEK® 2 AST-YS05 · BIOMERIEUX , INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VITEK® 2 AST-YS05
    Primary DI
    03573026529758
    Version / Model
    VITEK® 2 AST-YS05
    Company Name
    BIOMERIEUX , INC.
    Labeler DUNS
    086785110
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-09
    Public Version
    4
    Public Version Date
    2022-05-10
    Public Version Status
    Update
    Public Device Record Key
    2aee0d89-b816-494c-bfa3-ded8a0d64058
    Distribution End Date
    2021-08-19

    Device Description

    The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 systems as an in vitro test to determine the susceptibility of clinically significant yeast to antifungal agents

    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
    NGZ Susceptibility Test Plate, Antifungal

    GMDN Terms

    Code Name
    58605 General-microorganism antimicrobial susceptibility culture medium IVD

    Identifiers

    Type ID
    Package 03573026373047
    Primary 03573026529758

    Premarket Submissions

    Submission Number Supplement Number
    K061945 000
    K092454 000
    K101566 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius