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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Elecsys proBNP II Immunoassay

    DI: 07613336191569 · Model: 09315268160 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Elecsys proBNP II Immunoassay
    Primary DI
    07613336191569
    Version / Model
    09315268160
    Catalog Number
    09315268160
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-07
    Public Version
    2
    Public Version Date
    2023-08-25
    Public Version Status
    Update
    Public Device Record Key
    3280b056-098f-448b-b59d-71d39d8db9d3

    Device Description

    proBNP G2 Elecsys cobas e 100 V2.1

    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
    No
    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
    NBC Test, natriuretic peptide

    GMDN Terms

    Code Name
    47351 B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 07613336191569

    Premarket Submissions

    Submission Number Supplement Number
    K210546 000
    K223637 000