BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Procleix Ultrio Elite Assay

    DI: 00859882007566 · Model: 5K Kit Box 2 · GRIFOLS DIAGNOSTIC SOLUTIONS INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Procleix Ultrio Elite Assay
    Primary DI
    00859882007566
    Version / Model
    5K Kit Box 2
    Company Name
    GRIFOLS DIAGNOSTIC SOLUTIONS INC.
    Labeler DUNS
    056570085
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-27
    Public Version
    1
    Public Version Date
    2019-03-11
    Public Version Status
    New
    Public Device Record Key
    39ba0713-f60a-460f-bff7-e659228e1362

    Device Description

    The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.

    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

    GMDN Terms

    Code Name
    62052 HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00859882007566