BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Insulin ELISA Kit (DAKO)

    DI: 07350108630047 · Model: K2379 · Mercodia AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Insulin ELISA Kit (DAKO)
    Primary DI
    07350108630047
    Version / Model
    K2379
    Catalog Number
    K2379
    Company Name
    Mercodia AB
    Labeler DUNS
    354553091
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-08
    Public Version
    1
    Public Version Date
    2020-04-16
    Public Version Status
    New
    Public Device Record Key
    489c44c9-8951-45fb-88e9-07aa1017cd1d

    Device Description

    Insulin ELISA Kit provides a method for the quantitative determination of human insulin in serum or plasma. As with all diagnostic tests, a definitve clinical diagnosis should not be based on the results of a single test, but should be made by the physician after all clinical findings have been evaluated. The analysis should be performed by trained laboratory professionals.

    Device Characteristics

    Single Use
    Yes
    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

    Product Codes

    Code Name
    CFP Radioimmunoassay, Immunoreactive Insulin

    GMDN Terms

    Code Name
    54238 Insulin IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 07350108630047

    Customer Contacts

    Phone
    +4618570070
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius