BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ASTUTE140 Electronic Quality Control (EQC) Device

    DI: B0744000160 · Model: 400016 · BIOMERIEUX SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ASTUTE140 Electronic Quality Control (EQC) Device
    Primary DI
    B0744000160
    Version / Model
    400016
    Catalog Number
    400016
    Company Name
    BIOMERIEUX SA
    Labeler DUNS
    276816717
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-12
    Public Version
    5
    Public Version Date
    2026-01-23
    Public Version Status
    Update
    Public Device Record Key
    81f2d37d-0568-45bd-806e-9c234d3c74b9
    Distribution End Date
    2023-12-12

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    PIG Acute Kidney Injury Test System

    GMDN Terms

    Code Name
    56705 Fluorescent immunoassay analyser IVD, laboratory

    Identifiers

    Type ID
    Primary B0744000160