BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Access Estradiol Calibrator S0

    DI: 15099590231385 · Model: 33546 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Access Estradiol Calibrator S0
    Primary DI
    15099590231385
    Version / Model
    33546
    Catalog Number
    33546
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-23
    Public Version
    1
    Public Version Date
    2021-10-01
    Public Version Status
    New
    Public Device Record Key
    947032e1-812b-4a9a-9ebe-fad0c9d3d6b2

    Device Description

    The Access Estradiol Calibrator S0 is intended for use with Access Estradiol assay to dilute patient samples containing analyte concentrations greater than the analyte specific S5 calibrator

    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
    JIT Calibrator, Secondary

    GMDN Terms

    Code Name
    54152 Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 15099590231385