BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INTEGRATED DNA TECHNOLOGIES, INC.

    Reg #: 3004613294 · FEI: 3004613294 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    INTEGRATED DNA TECHNOLOGIES, INC.
    Registration Number
    3004613294
    FEI Number
    3004613294
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1710 Commercial Park
    City
    Coralville
    State
    IA
    ZIP
    52241
    Country
    US

    Owner / Operator

    Firm Name
    Integrated DNA Technologies, Inc.
    Operator Number
    10025742
    Address
    1710 Commercial Park
    City
    Coralville
    State
    IA
    Postal Code
    52241
    Country
    US
    Correspondent
    Ashleigh C Dawley, RAC

    Products

    Device Name Product Code
    Reagents For Molecular Diagnostic Test Systems PFT
    Lower Respiratory Microbial Nucleic Acid Detection System QBH
    Fungal Organisms, Nucleic Acid-Based Assay PEO
    Candida Species Nucleic Acid Detection System PII

    Proprietary Names

    10029288 - FUSIONPlex - HT Dx Reagents 24rxn - A 10029286 - FUSIONPlex - HT Dx Reagents 96rxn - A 10029290 - VARIANTPlex - HT Dx Reagents 96rxn - A 10029292 - VARIANTPlex - HT Dx Reagents 24rxn - A 10029289 - FUSIONPlex - HT Dx Reagents 24rxn - B 100029287 - FUSIONPlex - HT Dx Reagents 96rxn - B 10029293 - VARIANTPlex - HT Dx Reagents 24rxn - B 10029291 - VARIANTPlex - HT Dx Reagents 96rxn - B AspID PneumID AurisID CandID

    Establishment Types

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