BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Procleix Ultrio Plus Assay

    DI: 00859882007184 · Model: Controls 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 Plus Assay
    Primary DI
    00859882007184
    Version / Model
    Controls 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
    2018-02-06
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    e2fba1c0-68d1-4a3d-a79a-df41652cff1d

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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 00859882007184