BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AutoDELFIA Sample processor

    DI: 06438147334780 · Model: 1297-0110 · Wallac Oy
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AutoDELFIA Sample processor
    Primary DI
    06438147334780
    Version / Model
    1297-0110
    Catalog Number
    1297-0110
    Company Name
    Wallac Oy
    Labeler DUNS
    540156544
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-01
    Public Version
    3
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    1a408461-7998-45ee-a8e1-b947e6d6208a

    Device Description

    Used with 1235-5220 AutoDELFIA® System (SP and PP).

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KHO Fluorometer, For Clinical Use

    GMDN Terms

    Code Name
    56705 Fluorescent immunoassay analyser IVD, laboratory

    Identifiers

    Type ID
    Primary 06438147334780