INTEGRATED DNA TECHNOLOGIES, INC.

FDA Device Registration & Listing · Coralville, IA, US · Registration 3004613294

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004613294
FEI Number
3004613294
Entity Name
INTEGRATED DNA TECHNOLOGIES, INC.
City/State/Country
Coralville, IA, US
Establishment Address
1710 Commercial Park, Coralville, IA 52241, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Integrated DNA Technologies, Inc. (Owner Number: 10025742)
Owner / Operator Contact Address
1710 Commercial Park, Coralville, IA 52241, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PFT Reagents For Molecular Diagnostic Test Systems Clinical Chemistry Class 1 862.3800 2026-03-27
QBH Lower Respiratory Microbial Nucleic Acid Detection System Microbiology Class 2 866.3985 2021-12-27
PEO Fungal Organisms, Nucleic Acid-Based Assay Microbiology Class 2 866.3365 2021-12-27

Official Correspondent

Ashleigh Dawley, RAC

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Integrated DNA Technologies, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004613294. Last updated year: 2026. Please use registration number 3004613294 when referencing this establishment in official correspondence.
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