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Genmark Diagnostics, Incorporated

USA · Carlsbad

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, 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

15listed device types

Class I 0Class II 14Class III 0unclassified 1

plus 7 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 States7 registration records, 8 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: GENMARK DIAGNOSTICS, INC. · GENMARK DIAGNOSTICS INC.

FDA 510(k) clearances by year

12011 · K110786

12016 · K152612

22017 · K163636

22018 · K182690

12019 · K182619

12022 · K213236

FDA listed device types

showing 8 of 15

Human Metapneumovirus (Hmpv) Rna Assay System 1Respiratory Virus Panel Nucleic Acid Assay System 1Parainfluenza Multiplex Nucleic Acid Assay 1Mycoplasma Pneumoniae Dna Assay System 1Gram-Positive Bacteria And Their Resistance Markers 1Influenza A Virus Subtype Differentiation Nucleic Acid Assay 1Non-Sars Coronavirus Multiplex Nucleic Acid Assay 1Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213236	ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel	2022-04-27
US	K182619	ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel	2019-04-12
US	K182690	ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel	2018-12-21
BR	10287411659	Família cobas ePlex	Class II

Genmark Diagnostics, Incorporated

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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