BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Access HBsAg CALIBRATOR

    DI: 15099590806279 · Model: D22915 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Access HBsAg CALIBRATOR
    Primary DI
    15099590806279
    Version / Model
    D22915
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-16
    Public Version
    1
    Public Version Date
    2026-01-26
    Public Version Status
    New
    Public Device Record Key
    eb2e980c-54a0-413c-b137-70cd38a80019

    Device Description

    The Access HBsAg Calibrator is intended to calibrate the Access HBsAg and Access HBsAg Confirmatory assays for the in vitro qualitative detection and confirmation of hepatitis B surface antigen (HBsAg) in human serum and plasma using the DxI 9000 Access Immunoassay Analyzer.

    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

    GMDN Terms

    Code Name
    41999 Hepatitis B virus surface antigen IVD, calibrator

    Identifiers

    Type ID
    Primary 15099590806279