BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Access BNP II

    DI: 15099590786533 · Model: D06227 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Access BNP II
    Primary DI
    15099590786533
    Version / Model
    D06227
    Catalog Number
    D06227
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-30
    Public Version
    1
    Public Version Date
    2026-04-07
    Public Version Status
    New
    Public Device Record Key
    67f94c3c-56fc-4de0-9985-7a50e7ccffaa

    Device Description

    The Access BNP II test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: • as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset, acutely decompensated, or exacerbated heart failure • for the risk stratification of patients with acute coronary syndromes • for the risk stratification of patients with heart failure

    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
    No
    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
    NBC Test, Natriuretic Peptide

    GMDN Terms

    Code Name
    47352 B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 15099590786533