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Quidel Corporation

USA · San Diego

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Israel — 7 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 10Class II 10Class III 0unclassified 3

plus 37 registration records and 130 510(k), 2 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

9 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

14valid device licences

Class I 7Class II 7

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 1 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

8registrations

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 States37 registration records, 130 510(k), 2 PMA, 2 excluded

Brazil5 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: QUIDEL CORP. · QUIDEL CORPORATION

FDA 510(k) clearances by year

12001

32002

12003

12004

12005

12006

12007

12009

22010

32011

22012

112013

72014

22015

52016

72017

42018

12021

52023

12024

FDA listed device types

showing 8 of 23

Antisera, All Groups, Streptococcus Spp. 1Container, Specimen, Non-Sterile 1Mmp-9 Test System 1Fluorometer, For Clinical Use 1Campylobacter Spp. 1Antigens, Cf (Including Cf Control), Adenovirus 1-33 1Reagents, Clostridium Difficile Toxin 1Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231795	QuickVue COVID-19 Test	2024-03-22
US	K232286	Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument	2023-12-20
US	K233688	Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set	2023-12-13
BR	10259610174	Sofia Legionella FIA	Class II
BR	10259610154	ANALISADOR SOFIA	Class II
BR	80628810009	InflammaDry	Class II

Quidel Corporation

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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