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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Procleix WNV Assay

    DI: 00859882007009 · Model: 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 WNV Assay
    Primary DI
    00859882007009
    Version / Model
    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
    d11b24b0-d837-4521-908a-32e6ea7e4d38

    Device Description

    The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA 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
    49045 West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00859882007009