BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CODIAGNOSTICS

    Reg #: 3014214006 · FEI: 3014214006 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    15
    Establishment Types
    3
    Classifications
    8

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    Registration Details

    Registration Name
    CODIAGNOSTICS
    Registration Number
    3014214006
    FEI Number
    3014214006
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2401 S Foothill Dr Ste D
    City
    Salt Lake City
    State
    UT
    ZIP
    84109
    Country
    US

    Owner / Operator

    Firm Name
    Co-Diagnostics, Inc.
    Operator Number
    10052747
    Address
    2401 Foothill Dr. Ste D
    City
    Salt Lake City
    State
    UT
    Postal Code
    84109
    Country
    US
    Correspondent
    Marisa Frost

    Products

    Device Name Product Code
    Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices QLT
    Research Use Only/Microbiology OTT
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    Investigational Use Only - Microbiology PCY
    System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex MWA
    Reagents, Zika Virus Nucleic Acid POA
    System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen PEU
    Instrumentation For Clinical Multiplex Test Systems NSU

    Proprietary Names

    Logix Smart ABC (Influenza A/B, SARS-CoV-2) Logix Smart HIV Logix Smart HCV Logix Smart HBV Logix Smart DENV Logix Smart MAL Logix Smart HPV Logix Smart ZIKV Logix Smart ZDC (ZIKV, DENV, CHIKV) Logix Smart Coronavirus Disease 2019 (COVID-19) - 5,000 reactions Logix Smart Coronavirus Disease 2019 (COVID-19) - 100 reactions Logix Smart Coronavirus Disease 2019 (COVID-19) - 250 reactions Logix Smart MTB Mycobacterium Tuberculosis Drug Resistance Panel Kit CoDx Box Cycler

    Establishment Types

    Manufacture Device in the United States for Export Only Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device