BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Panther Fusion

    DI: 15420045510470 · Model: INTERNAL CONTROL-X, 960T, IVD · Hologic, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Panther Fusion
    Primary DI
    15420045510470
    Version / Model
    INTERNAL CONTROL-X, 960T, IVD
    Catalog Number
    PRD-04476
    Company Name
    Hologic, Inc.
    Labeler DUNS
    050579217
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-30
    Public Version
    1
    Public Version Date
    2019-08-07
    Public Version Status
    New
    Public Device Record Key
    6eca6d64-7d7b-4900-9752-0f5f7242bf83

    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

    Product Codes

    Code Name
    NJR Nucleic acid amplification assay system, group b streptococcus, direct specimen test

    GMDN Terms

    Code Name
    51753 Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 15420045510470