BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Access Total IgE

    DI: 15099590221324 · Model: 35000 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Access Total IgE
    Primary DI
    15099590221324
    Version / Model
    35000
    Catalog Number
    35000
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    3
    Public Version Date
    2018-12-24
    Public Version Status
    Update
    Public Device Record Key
    bcf6cdce-4c45-4ddf-b074-2cad25e09bf6
    Distribution End Date
    2016-12-30

    Device Description

    The Access Total IgE assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative determination of total E (IgE) levels in human serum and plasma (heparin, EDTA) using the Access 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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DGC Ige, Antigen, Antiserum, Control

    GMDN Terms

    Code Name
    53775 Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 15099590221324