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Quidel Cardiovascular, Inc.

USA · San Diego

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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

20listed device types

Class I 4Class II 15Class III 0unclassified 1

plus 28 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

14 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class III 1

12 including historic records

TWTaiwanTFDA

14valid device licences

Class I 1Class II 13

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

7active ARTG entries

IVD Class 1 2IVD Class 2 3IVD Class 3 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 2Class 2b 2

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 States28 registration records, 2 510(k), 0 PMA, 3 excluded

Brazil3 confirmed, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: Quidel Cardiovascular Inc. · QUIDEL CARDIOVASCULAR INC. · QUIDEL CARDIOVASCULAR INC.,

FDA 510(k) clearances by year

12019 · K182719

12020 · K200363

FDA listed device types

showing 8 of 20

Myoglobin, Antigen, Antiserum, Control 1Enzyme Immunoassay, Opiates 1Radioimmunoassay, Tricyclic Antidepressant Drugs 1Enzyme Immunoassay, Benzodiazepine 1Fibrin Split Products 1Enzyme Immunoassay, Amphetamine 1Immunoassay Method, Troponin Subunit 1Enzyme Immunoassay, Cocaine 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200363	Quidel Triage® TOX Drug Screen, 94600	2020-03-11
US	K182719	Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro	2019-06-19
BR	81246986866	Família Quidel Triage PLGF	Class II
BR	81246986867	Família Quidel Triage TOX Drug Screen 94600	Class II
BR	81246986868	Família Quidel Triage MeterPro	Class II
CA	60700	TRIAGE TOX DRUG SCREEN	Class III

Quidel Cardiovascular, 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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