BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Access Hybritech PSA

    DI: 15099590701673 · Model: C22845 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Access Hybritech PSA
    Primary DI
    15099590701673
    Version / Model
    C22845
    Catalog Number
    C22845
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-30
    Public Version
    1
    Public Version Date
    2025-06-09
    Public Version Status
    New
    Public Device Record Key
    c15d3b06-63e8-4e8d-bf13-0b0132ae83ba

    Device Description

    The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.

    Device Characteristics

    Single Use
    Yes
    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
    MTF Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer

    GMDN Terms

    Code Name
    54665 Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 15099590701673