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CorDx, Inc.

USA · Alpharetta

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Singapore — 2 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

13listed device types

Class I 1Class II 11Class III 0unclassified 1

plus 7 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

pendingnot queried

SGSingaporeHSA SMDR

13device registrations

CLASS B 8CLASS C 1CLASS D 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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, 2 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: CorDx, Inc.

FDA 510(k) clearances by year

12024 · K240728

12026 · K253882

FDA listed device types

showing 8 of 13

Test, Luteinizing Hormone (Lh), Over The Counter 1Kit, Test, Pregnancy, Hcg, Over The Counter 1Enzyme Immunoassay, Opiates 1Test, Opiates, Over The Counter 1Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings 1Enzyme Immunoassay, Amphetamine 1Over-The-Counter Covid-19 Antigen Test 1Enzyme Immunoassay, Cannabinoids 1

Market	Identifier	Name	Class / date
US	K253882	CorDx Tyfast COVID-19 Ag Rapid Test Rx	2026-06-01
US	K240728	CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test	2024-06-21

CorDx, Inc.

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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