BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COPAN DIAGNOSTICS, INC.

    Reg #: 2436875 · FEI: 1000521444 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    62
    Establishment Types
    3
    Classifications
    14

    Registration Details

    Registration Name
    COPAN DIAGNOSTICS, INC.
    Registration Number
    2436875
    FEI Number
    1000521444
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    26055, 26083 & 26087 Jefferson Avenue
    City
    Murrieta
    State
    CA
    ZIP
    92562
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042970

    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
    Correspondent
    ELISABETTA ZANELLA

    Products

    Device Name Product Code
    Culture Media, Selective Broth JSD
    Kit, Quality Control For Culture Media JTR
    Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP
    Microbial Nucleic Acid Storage And Stabilization Device QBD
    Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ
    Dna-Reagents, Neisseria LSL
    Culture Media, Non-Propagating Transport JSM
    General Purpose Reagent PPM
    Culture Media, Non-Selective And Non-Differential JSG
    Micro Pipette JRC
    Device, Specimen Collection LIO
    Container, Specimen Mailer And Storage, Sterile KDT
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Applicator, Absorbent Tipped, Sterile KXG

    Proprietary Names

    GN Broth SELENITEBroth LIMBroth TSBBroth with Salt CABroth CryoBank Xpert Vaginal/Endocervical Specimen Collection Kit Xpert CT/NG Xpert Swab Specimen Collectin Kit Xpert Urine Specimen Collection Kit Cepheid Xpert Urine Specimen Collection Kit Sample Diluent Tube Copan SLsolution Snot Buster Saline Solution 0.85% BHI (Brain Heart Infusion) Broth THIOBroth Transfer Pipettes ACT Transfer Pipettes InfoLab Transfer Pipettes AeroMed Transfer Pipettes HealthLink UTM Cepheid Xpert Xpress Nasopharyngeal Collection Kit Copan Universal Transport Medium UTM-RT Quest Diagnostics VCM BD BBL UVT BD Universal Viral Transport Dry Swab Tube Plain Dry Screw Cap Tube Sterile Dry Tube BC+ UriFree Copan FLOQSwabs with Empty Tube Hardy SpeedStreakers InfoLab Loops Dove Medical Supply Loops HealthLink Inc. Loops and Needles Inoculation Loops Inoculation Needles BD Inoculation Loops Inoculation Spreaders Troy Biologicals Loops and Needles Disposable Transfer Pipettes Double Spreader Sputum Dipper UniVerse® dispensing tube UniVerse® Dispensing Tube - Bottle MSwab bag for UniVerse BD FecalSwab Copan FecalSwab BD FCT Copan Universal Transport Medium (UTM-RT) System NuFoam Swab Rayon Fiber Swab, Sterile Nylon Fiber Swab, Sterile Cotton Fiber Swab, Sterile Polyester Fiber Swab, Sterile FLOQBrush Buccal Swab CLASSIQSwab Foam Swab, Sterile FLOQSwab

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)