Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021047648

FEI Number

3021047648

Entity Name

GENOMADIX INC

City/State/Country

Kanata (Ottawa) Ontario, CA

Establishment Address

340 Legget Drive, Suite 180, Kanata (Ottawa) Ontario K2K1Y6, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Genomadix Inc (Owner Number: 10088570)

Owner / Operator Contact Address

340 Legget Drive, Suite 180, Kanata (Ottawa), CA-ON K2K1Y6, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220026

PMA Number

N/A

All Registered Proprietary Names

Genomadix Cube CYP2C19 System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NTI	Drug Metabolizing Enzyme Genotyping Systems	Clinical Toxicology	Class 2	862.3360	2023-08-17

Official Correspondent

Bern Johnson

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Genomadix 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 3021047648. Last updated year: 2026. Please use registration number 3021047648 when referencing this establishment in official correspondence.