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CITEST DIAGNOSTICS INC.

Canada · Vancouver

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Israel — 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

23listed device types

Class I 0Class II 21Class III 0unclassified 2

plus 1 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

9active device licences

Class II 9

73 including historic records

TWTaiwanTFDA

7valid device licences

Class I 7

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States1 registration records, 0 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: CITEST DIAGNOSTICS INC.

FDA listed device types

showing 8 of 23

Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Thin Layer Chromatography, Methamphetamine 1Test, Benzodiazepine, Over The Counter 1Test, Tricyclic Antidepressants, Over The Counter 1Enzyme Immunoassay, Amphetamine 1Enzyme Immunoassay, Methadone 1Enzyme Immunoassay, Barbiturate 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	81325990437	Família Teste Rápido de Gravidez por hCG em Bastão (Urina) Para Autote	Class II
BR	81325990438	Família Cassete de Teste Rápido de Gravidez por hCG (Urina) Para Autot	Class II
CA	103328	CITEST THC50 RAPID TEST DIPSTICK(URINE)	Class II
CA	103342	CITEST ACE5000 RAPID TEST DIPSTICK (URINE)	Class II
CA	103395	CITEST FYL20 RAPID TEST CASSETTE (URINE)	Class II

CITEST DIAGNOSTICS INC.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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