BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Access BNP QC

    DI: 15099590750954 · Model: 98201 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Access BNP QC
    Primary DI
    15099590750954
    Version / Model
    98201
    Catalog Number
    98201
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-08-18
    Public Version
    1
    Public Version Date
    2021-08-26
    Public Version Status
    New
    Public Device Record Key
    34194119-6303-4164-b39f-e365f04c3ae2

    Device Description

    The Access BNP QC Controls are intended for monitoring the performance of the Access BNP test using the Beckman Coulter Access Family of Immunoassay Systems.

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    47354 B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

    Identifiers

    Type ID
    Primary 15099590750954