BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Aptima BV assay

    Reg #: 2024800 · FEI: 2024800 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Hologic, Inc.
    Registration Number
    2024800
    FEI Number
    2024800
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    10210 Genetic Center Dr
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190452

    Owner / Operator

    Firm Name
    HOLOGIC, INC.
    Operator Number
    9007676
    Address
    250 Campus Drive, --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    Products

    Device Name Product Code
    Instrumentation For Clinical Multiplex Test Systems NSU
    Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays PMN
    Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System PQA

    Proprietary Names

    Aptima BV assay Aptima BV Assay Calibrator Kit Aptima BV Assay Controls Kit

    Establishment Types

    Manufacture Medical Device