BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Xpert Urine Specimen Collection Kit

    Reg #: 2436875 · FEI: 1000521444 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    COPAN DIAGNOSTICS, INC.
    Registration Number
    2436875
    FEI Number
    1000521444
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    26055, 26083 & 26087 Jefferson Avenue
    City
    Murrieta
    State
    CA
    ZIP
    92562
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190441

    Owner / Operator

    Firm Name
    COPAN ITALIA Spa
    Operator Number
    9016900
    Address
    Via F. Perotti 10, 18
    City
    Brescia
    State
    IT-BS
    Postal Code
    25125
    Country
    IT

    Products

    Device Name Product Code
    Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP
    Dna-Reagents, Neisseria LSL
    Microbial Nucleic Acid Storage And Stabilization Device QBD
    Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ

    Proprietary Names

    Xpert Urine Specimen Collection Kit Xpert Swab Specimen Collectin Kit Xpert CT/NG Xpert Vaginal/Endocervical Specimen Collection Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)