BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ARCHITECT

    DI: 00380740204020 · Model: 04T0401 · ABBOTT IRELAND
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ARCHITECT
    Primary DI
    00380740204020
    Version / Model
    04T0401
    Catalog Number
    04T0401
    Company Name
    ABBOTT IRELAND
    Labeler DUNS
    989964119
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-24
    Public Version
    1
    Public Version Date
    2025-11-03
    Public Version Status
    New
    Public Device Record Key
    76962836-b787-4662-9c73-ec8d497401b3

    Device Description

    Lipase2 Calibrator

    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
    CHI LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

    GMDN Terms

    Code Name
    53109 Lipase IVD, calibrator

    Identifiers

    Type ID
    Primary 00380740204020

    Customer Contacts

    Phone
    +1(877)422-2688
    Email
    [email protected]

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    High: 0 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – -20 Degrees Celsius