BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IGF-1 ELISA

    DI: 05400569000209 · Model: KAP1581 · Diasource Immunoassays S.A. SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IGF-1 ELISA
    Primary DI
    05400569000209
    Version / Model
    KAP1581
    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
    2020-09-11
    Public Version
    2
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    12a678fb-dba5-4462-816a-c91e65714036

    Device Description

    IGF-1 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
    58408 Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 05400569000209