BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RIDASCREEN® Pancreatic Elastase ELISA

    DI: 04049095070495 · Model: G09038USA · R-Biopharm AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RIDASCREEN® Pancreatic Elastase ELISA
    Primary DI
    04049095070495
    Version / Model
    G09038USA
    Catalog Number
    G09038USA
    Company Name
    R-Biopharm AG
    Labeler DUNS
    321850323
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-26
    Public Version
    1
    Public Version Date
    2026-04-03
    Public Version Status
    New
    Public Device Record Key
    21b95b7e-9320-4d6c-bec3-f35155a44393

    Device Description

    Pancreatic Elastase ELISA is an IVD test for the quantitative determination of pancreatic elastase in stool samples of human origin by a laboratory professional user.

    Device Characteristics

    Single Use
    No
    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
    Yes
    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
    53145 Pancreatic elastase (PE) IVD, reagent

    Identifiers

    Type ID
    Primary 04049095070495