BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ScheBo® Pancreatic Elastase 1™

    DI: 04260152080701 · Model: ELISA Stool Test · ScheBo r. Biotech Aktiengesellschaft
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ScheBo® Pancreatic Elastase 1™
    Primary DI
    04260152080701
    Version / Model
    ELISA Stool Test
    Catalog Number
    07
    Company Name
    ScheBo r. Biotech Aktiengesellschaft
    Labeler DUNS
    326980364
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-30
    Public Version
    2
    Public Version Date
    2022-08-05
    Public Version Status
    Update
    Public Device Record Key
    82b5359b-2d66-49f7-b254-48c6bcabb7c6

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    JNN P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin

    GMDN Terms

    Code Name
    53142 Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 04260152080701