BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Alinity m

    DI: 00884999047730 · Model: 08N45-095 · ABBOTT MOLECULAR INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Alinity m
    Primary DI
    00884999047730
    Version / Model
    08N45-095
    Catalog Number
    08N45-095
    Company Name
    ABBOTT MOLECULAR INC.
    Labeler DUNS
    878263359
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-02
    Public Version
    2
    Public Version Date
    2022-12-29
    Public Version Status
    Update
    Public Device Record Key
    a155ae5c-eccd-4856-9cd8-c4bd883f3530

    Device Description

    Alinity m HIV-1 AMP Kit

    Device Characteristics

    Single Use
    Yes
    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
    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
    MZF Test, HIV detection

    GMDN Terms

    Code Name
    30768 HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00884999047730