BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COPAN Diagnostics, Inc.

    Reg #: 3017063217 · FEI: 3017063217 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    31
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    COPAN Diagnostics, Inc.
    Registration Number
    3017063217
    FEI Number
    3017063217
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2728 Loker Ave. W
    City
    Carlsbad
    State
    CA
    ZIP
    92010
    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, Non-Propagating Transport JSM
    Device, Specimen Collection LIO
    General Purpose Reagent PPM
    Container, Specimen Mailer And Storage, Sterile KDT
    Applicator, Absorbent Tipped, Sterile KXG
    Micro Pipette JRC

    Proprietary Names

    Copan Universal Transport Medium (UTM-RT) System Sample Diluent Tube Copan SLsolution Snot Buster Saline Solution 0.85% 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 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 Transfer Pipettes ACT Transfer Pipettes InfoLab Transfer Pipettes AeroMed Transfer Pipettes

    Establishment Types

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