BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IGFBP-3 Elisa

    DI: 05400569000087 · Model: KAP1171 · Diasource Immunoassays S.A. SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IGFBP-3 Elisa
    Primary DI
    05400569000087
    Version / Model
    KAP1171
    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
    2020-01-09
    Public Version
    2
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    e51d43a9-c335-46b8-a4a5-4cee994e3e9a

    Device Description

    IGFBP-3 Elisa

    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
    No
    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
    OAM Immunoassay, insulin-like growth factor binding protein-1

    GMDN Terms

    Code Name
    58409 Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 05400569000087