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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Procleix Ultrio Assay

    DI: 00859882007351 · Model: Negative Calibrators Kit · 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 Assay
    Primary DI
    00859882007351
    Version / Model
    Negative Calibrators Kit
    Company Name
    GRIFOLS DIAGNOSTIC SOLUTIONS INC.
    Labeler DUNS
    056570085
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-03
    Public Version
    1
    Public Version Date
    2018-09-03
    Public Version Status
    New
    Public Device Record Key
    497a5265-3564-4bc9-baf2-f6fafbed544f

    Device Description

    The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.

    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
    48216 HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00859882007351