BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Audit MicroControls Control LQ COVID-19 Antibodies

    DI: B085K077M60 · Model: K077M-6 · AALTO SCIENTIFIC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Audit MicroControls Control LQ COVID-19 Antibodies
    Primary DI
    B085K077M60
    Version / Model
    K077M-6
    Company Name
    AALTO SCIENTIFIC
    Labeler DUNS
    077974989
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-06
    Public Version
    2
    Public Version Date
    2020-10-06
    Public Version Status
    Update
    Public Device Record Key
    2a5203bc-c0af-4858-bb8d-4eea6139c44e

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    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

    GMDN Terms

    Code Name
    64983 SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control

    Identifiers

    Type ID
    Primary B085K077M60