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LumiQuick Diagnostics, Inc.

USA · Santa Clara CA · www.lumiquick.com

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

0UDI-DI device records

USUnited StatesFDA openFDA

59listed device types

Class I 10Class II 43Class III 0unclassified 6

plus 53 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

9registered devices

Class II 9

26 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

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 States53 registration records, 1 510(k), 0 PMA

Brazil9 confirmed, 0 excluded

Manufacturer names merged into this page: LUMIQUICK DIAGNOSTICS, INC. · RAPID DIAGNOSTICS, DIVISION OF LUMIQUICK DIAGNOSTICS INC. · LUMIQUICK DIAGNOSTICS · LUMIQUICK DIAGNOSTICS, INC

FDA 510(k) clearances by year

12013 · K130213

FDA listed device types

showing 8 of 59

Test Reagents For Ethyl Alcohol 1Kit, Test, Pregnancy, Hcg, Over The Counter 1Thin Layer Chromatography, Propoxyphene 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. 1Test, Propoxyphene, Over The Counter 1Devices Detecting Influenza A, B, And C Virus Antigens 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K130213	QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE	2013-10-18
BR	80464810772	Helicobacter pylori IgM	Class II
BR	80464810821	OxiStress GSH/GSSG-412 Assay Kit	Class II
BR	80464810822	QuickProfileTM OxiStressTM MDA-586 Assay Kit	Class II

LumiQuick Diagnostics, 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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