BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INS-IRMA

    DI: 05400569000438 · Model: KIP1251/KIP1254 · Diasource Immunoassays S.A. SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INS-IRMA
    Primary DI
    05400569000438
    Version / Model
    KIP1251/KIP1254
    Company Name
    Diasource Immunoassays S.A. SA
    Labeler DUNS
    458777323
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-15
    Public Version
    1
    Public Version Date
    2020-01-23
    Public Version Status
    New
    Public Device Record Key
    e0cd9ed3-8867-4ad0-a328-54c2931c7975

    Device Description

    INS-IRMA

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    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 05400569000438