BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Preciset Lp(a) Gen.2

    DI: 04015630930609 · Model: 05852641190 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Preciset Lp(a) Gen.2
    Primary DI
    04015630930609
    Version / Model
    05852641190
    Catalog Number
    05852641190
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-27
    Public Version
    1
    Public Version Date
    2025-06-04
    Public Version Status
    New
    Public Device Record Key
    b0b7384a-afed-47cd-9304-11c31f7b6ed0

    Device Characteristics

    Single Use
    No
    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
    JIT Calibrator, secondary

    GMDN Terms

    Code Name
    41417 Lipoprotein A IVD, calibrator

    Identifiers

    Type ID
    Primary 04015630930609