BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    APTIMA

    DI: 15420045509160 · Model: M GEN, CALIBRATOR 100T, AS, IVD · Hologic, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    APTIMA
    Primary DI
    15420045509160
    Version / Model
    M GEN, CALIBRATOR 100T, AS, IVD
    Catalog Number
    PRD-03393 / PRD-03919
    Company Name
    Hologic, Inc.
    Labeler DUNS
    153623137
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-25
    Public Version
    2
    Public Version Date
    2022-10-05
    Public Version Status
    Update
    Public Device Record Key
    e5a5a1cb-7392-46e9-90bc-83b476efe10a

    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
    QEP Mycoplasma Genitalium Nucleic Acid Detection System

    GMDN Terms

    Code Name
    47322 Mycoplasma genitalium nucleic acid IVD, calibrator

    Identifiers

    Type ID
    Primary 15420045509160