BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Procleix

    DI: 15420045500341 · Model: West Nile Virus 5K · Hologic, Inc.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Procleix
    Primary DI
    15420045500341
    Version / Model
    West Nile Virus 5K
    Catalog Number
    302181
    Company Name
    Hologic, Inc.
    Labeler DUNS
    050579217
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-08-06
    Public Version
    3
    Public Version Date
    2020-10-15
    Public Version Status
    Update
    Public Device Record Key
    4afe8261-2221-4bc5-8a68-e14962447963
    Distribution End Date
    2017-01-31

    Device Description

    FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    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 15420045500341