BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Alinity m

    DI: 00884999050709 · Model: 09N85-095 · ABBOTT MOLECULAR INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Alinity m
    Primary DI
    00884999050709
    Version / Model
    09N85-095
    Catalog Number
    09N85-095
    Company Name
    ABBOTT MOLECULAR INC.
    Labeler DUNS
    878263359
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-30
    Public Version
    1
    Public Version Date
    2025-06-09
    Public Version Status
    New
    Public Device Record Key
    fa698cdb-656d-497b-a086-9bfd3c2549de

    Device Description

    Alinity m BKV AMP Kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    No
    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

    Product Codes

    Code Name
    QMI Nucleic acid amplification test for the quantitation of BK virus (BK) DNA

    GMDN Terms

    Code Name
    49849 BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00884999050709

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K241921 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -25 – -15 Degrees Celsius