BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Alinity m

    DI: 00884999048652 · 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
    00884999048652
    Version / Model
    1.00
    Catalog Number
    08N50-03A
    Company Name
    ABBOTT MOLECULAR INC.
    Labeler DUNS
    878263359
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-04
    Public Version
    2
    Public Version Date
    2022-03-22
    Public Version Status
    Update
    Public Device Record Key
    f5dbc417-6264-4cbd-b591-13aead04d9c5

    Device Description

    Alinity m HCV 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
    MZP Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

    GMDN Terms

    Code Name
    43472 Laboratory instrument/analyser application software IVD

    Identifiers

    Type ID
    Primary 00884999048652

    Customer Contacts

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