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DNA GENOTEK, INC.

Canada · Ottawa Ontario

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 4Class II 3Class III 0unclassified 3

plus 17 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class I 17

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

IVD Class 1 7

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States17 registration records, 8 510(k), 0 PMA

Brazil17 confirmed, 0 excluded

Manufacturer names merged into this page: DNA GENOTEK, INC. · DNA GENOTEK INC.

Business registration

Legal name: DNA Genotek Inc.
Corporation number: 7935226
Registration status: Active
Legal form: Canada Business Corporations Act
Incorporated: 2011-08-17
Registered address: 500 PALLADIUM DRIVE, KANATA, ON, K2V 1C2

Business registration data from Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12011

12015

22016

12020

12021

12022

12026

FDA listed device types

showing 8 of 10

Applicator, Absorbent Tipped, Non-Sterile 1General Purpose Reagent 1Container, Specimen Mailer And Storage, Non-Sterile 1Device, Specimen Collection 1Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay 1Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples 1Dna Specimen Collection, Saliva 1Research Use Only/Microbiology 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254121	Colli-PeeDx Urine Collection Kit	2026-06-10
US	K212745	ORAcollect®Dx	2022-10-27
US	DEN200040	OMNIgene GUT Dx	2021-11-03
BR	80117580986	OMNIgene ORAL	Class I
BR	80117580768	OMNIgene GUT	Class I
BR	80504680003	FAMÍLIA COLETOR DE SALIVA EXTRAÇÃO DE DNA ORAGENE	Class I

DNA GENOTEK, INC.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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