BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Audit MicroControls Linearity FLQ Anemia for Abbott Systems

    DI: B085K948M50 · Model: K948M-5 · AALTO SCIENTIFIC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Audit MicroControls Linearity FLQ Anemia for Abbott Systems
    Primary DI
    B085K948M50
    Version / Model
    K948M-5
    Company Name
    AALTO SCIENTIFIC
    Labeler DUNS
    077974989
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-29
    Public Version
    2
    Public Version Date
    2025-12-10
    Public Version Status
    Update
    Public Device Record Key
    fb4fab29-feb8-45a2-997c-a75864a48ef8
    Distribution End Date
    2025-04-04

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    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

    GMDN Terms

    Code Name
    60998 Multiple anaemia-related analyte IVD, control

    Identifiers

    Type ID
    Primary B085K948M50