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CORGENIX, INC.

USA · Broomfield

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, South Korea, Australia, Russia — 6 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 0Class II 8Class III 0unclassified 2

plus 19 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

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

8active device licences

Class II 8

23 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 2 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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 States19 registration records, 23 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: CORGENIX, INC. · CORGENIX INC. · CORGENIX, INC · CORGENIX INC

FDA 510(k) clearances by year

41998

12000

72001

22002

42003

32004

12007

12008

FDA listed device types

showing 8 of 10

System, Test, Systemic Lupus Erythematosus 1Galectin-3 In Vitro Diagnostic Assay 1System, Test, Anticardiolipin Immunological 1Test, Qualitative And Quantitative Factor Deficiency 1System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) 111-Dehydro Thromboxane B2 Kit, Urinary 1Control, Plasma, Abnormal 1Plasma, Control, Normal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K072032	IGG ANTI-ATHEROX TEST KIT	2008-04-04
US	K062025	ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136	2007-05-29
US	K042680	RHIGENE HEP-ANA TEST SYSTEM	2004-11-19
BR	10230730161	Corgenix Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit	Class II
BR	10230730162	Corgenix Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit	Class II
BR	10230730159	Corgenix Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit	Class II
CA	72233	REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT	Class II
CA	6465	READDS ANTINUCLEAR ANTIBODY SCREENING TEST	Class II
CA	7539	REAADS SSA \ SSB PROFILE TEST KIT	Class II

CORGENIX, 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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