BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    APTIMA

    DI: 15420045515017 · Model: PANTHER,TRICH REFRIG,V2,250T,READY MADE · Hologic, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    APTIMA
    Primary DI
    15420045515017
    Version / Model
    PANTHER,TRICH REFRIG,V2,250T,READY MADE
    Catalog Number
    PRD-07041
    Company Name
    Hologic, Inc.
    Labeler DUNS
    050579217
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-07-28
    Public Version
    1
    Public Version Date
    2022-08-05
    Public Version Status
    New
    Public Device Record Key
    1babaf64-5e22-4d76-a70f-93fe0c5de954

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    OUY Trichomonas vaginalis nucleic acid amplification test system
    QEP Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections

    GMDN Terms

    Code Name
    52475 Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 15420045515017

    Premarket Submissions

    Submission Number Supplement Number
    K200436 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius