BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ACCESS HIV Ag/Ab combo

    DI: 15099590745158 · Model: C39450 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ACCESS HIV Ag/Ab combo
    Primary DI
    15099590745158
    Version / Model
    C39450
    Catalog Number
    C39450
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-15
    Public Version
    1
    Public Version Date
    2024-03-25
    Public Version Status
    New
    Public Device Record Key
    0a49fb27-fd7a-49b9-927e-f6c469f53dd3

    Device Description

    The Access HIV Ag/Ab combo assay is a paramagnetic particle, chemiluminescent immunoassay for the simultaneous qualitative in vitro detection and differentiation of HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and/or HIV-2 in human pediatric (ages 2 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, tripotassium (K3) EDTA, sodium citrate, acid-citrate-dextrose (ACD) and citrate phosphate-dextrose (CPD)] using the DxI 9000 Access Immunoassay Analyzer. The Access HIV Ag/Ab combo assay is intended to be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2infection in pregnant women. The Access HIV Ag/Ab combo assay is for use on the DxI 9000 Access Immunoassay Analyzer only. This assay is not intended for use for screening donors of blood or blood products or human cells, tissues, or cellular or tissue-based products (HCT/Ps)

    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

    Product Codes

    Code Name
    MZF Test, Hiv Detection

    GMDN Terms

    Code Name
    48446 HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 15099590745158