BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Alinity m

    DI: 00884999048645 · Model: 1.00 · 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
    00884999048645
    Version / Model
    1.00
    Catalog Number
    08N47-03A
    Company Name
    ABBOTT MOLECULAR INC.
    Labeler DUNS
    878263359
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-23
    Public Version
    2
    Public Version Date
    2022-03-22
    Public Version Status
    Update
    Public Device Record Key
    2a7f82e3-4f89-4f22-8492-dc12bc631664

    Device Description

    Alinity m HBV Application Specification File

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    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
    MKT Hepatitis Viral B DNA Detection

    GMDN Terms

    Code Name
    43472 Laboratory instrument/analyser application software IVD

    Identifiers

    Type ID
    Primary 00884999048645

    Customer Contacts

    Phone
    +1(800)553-7042
    Email
    [email protected]