BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hologic Aptima Urine

    Reg #: 3012598266 · FEI: 3012598266 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MOLECULAR TESTING LABS
    Registration Number
    3012598266
    FEI Number
    3012598266
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14401 SE 1ST Street
    City
    Vancouver
    State
    WA
    ZIP
    98684
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180681

    Owner / Operator

    Firm Name
    Molecular Testing Labs
    Operator Number
    10081703
    Address
    14401 SE 1ST Street
    City
    Vancouver
    State
    WA
    Postal Code
    98684
    Country
    US

    Products

    Device Name Product Code
    Dna-Reagents, Neisseria LSL
    Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ

    Proprietary Names

    Hologic Aptima Urine

    Establishment Types

    Repack or Relabel Medical Device