BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lipase colorimetric assay

    DI: 04015630917570 · Model: 3029590322 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lipase colorimetric assay
    Primary DI
    04015630917570
    Version / Model
    3029590322
    Catalog Number
    3029590322
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-01-18
    Public Version
    2
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    974831b9-8b02-4998-9d15-562ac2080c3b

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CHI LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

    GMDN Terms

    Code Name
    53108 Lipase IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 04015630917570