BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Copan Universal Transport Medium UTM-RT

    Reg #: 3017063217 · FEI: 3017063217 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    COPAN Diagnostics, Inc.
    Registration Number
    3017063217
    FEI Number
    3017063217
    Status
    Active
    Expiry Year
    2025
    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

    Products

    Device Name Product Code
    Culture Media, Non-Propagating Transport JSM

    Proprietary Names

    Copan Universal Transport Medium UTM-RT Cepheid Xpert Xpress Nasopharyngeal Collection Kit BD BBL UVT BD Universal Viral Transport Quest Diagnostics VCM HealthLink UTM

    Establishment Types

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