Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014214006

FEI Number

3014214006

Entity Name

CODIAGNOSTICS

City/State/Country

Salt Lake City, UT, US

Establishment Address

2401 S Foothill Dr Ste D, Salt Lake City, UT 84109, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Co-Diagnostics, Inc. (Owner Number: 10052747)

Owner / Operator Contact Address

2401 Foothill Dr. Ste D, Salt Lake City, UT 84109, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 MAL Logix Smart HBV Logix Smart HIV Logix Smart HCV Logix Smart DENV Logix Smart HPV Logix Smart ZDC (ZIKV, DENV, CHIKV) Logix Smart MTB Logix Smart ZIKV Logix Smart ZDC (ZIKV, DENV, CHIKV) Mycobacterium Tuberculosis Drug Resistance Panel Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QLT	Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices	Unknown	Class N	N/A	2020-12-31
OTT	Research Use Only/Microbiology	Unknown	Class N	N/A	2018-11-15
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-03-05
PCY	Investigational Use Only - Microbiology	Unknown	Class N	N/A	2018-11-15
MWA	System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex	Microbiology	Class 2	866.3372	2016-09-26
POA	Reagents, Zika Virus Nucleic Acid	Unknown	Class N	N/A	2016-09-26
PEU	System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen	Microbiology	Class 2	866.3373	2016-09-26

Official Correspondent

Marisa Frost

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Co-Diagnostics, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2025	Luminex Molecular Diagnostics Inc	N	NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014214006. Last updated year: 2026. Please use registration number 3014214006 when referencing this establishment in official correspondence.