BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Audit MicroControls Linearity FD HE4, HER2 Tumor Markers

    DI: B085K738M50 · Model: K738M-5 · AALTO SCIENTIFIC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Audit MicroControls Linearity FD HE4, HER2 Tumor Markers
    Primary DI
    B085K738M50
    Version / Model
    K738M-5
    Company Name
    AALTO SCIENTIFIC
    Labeler DUNS
    077974989
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-27
    Public Version
    1
    Public Version Date
    2018-04-27
    Public Version Status
    New
    Public Device Record Key
    af10e131-609f-4481-8078-910b02e289a4

    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
    38220 Multiple tissue-associated protein/tumour marker IVD, control

    Identifiers

    Type ID
    Primary B085K738M50