BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VIDAS® 3 ASSAY DILUTION CUP

    DI: 03573026612849 · Model: VIDAS® 3 ASSAY DILUTION CUP · BIOMERIEUX SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VIDAS® 3 ASSAY DILUTION CUP
    Primary DI
    03573026612849
    Version / Model
    VIDAS® 3 ASSAY DILUTION CUP
    Company Name
    BIOMERIEUX SA
    Labeler DUNS
    276816717
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-28
    Public Version
    3
    Public Version Date
    2022-09-26
    Public Version Status
    Update
    Public Device Record Key
    124b1ee7-0a9c-46f5-be6c-04cfd0aacb9f

    Device Description

    The VIDAS®3 can perform dilutions and manage two dilution cup racks holding 16 cups each.

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

    GMDN Terms

    Code Name
    56705 Fluorescent immunoassay analyser IVD, laboratory

    Identifiers

    Type ID
    Package 03573026377427
    Primary 03573026612849

    Premarket Submissions

    Submission Number Supplement Number
    K141133 000