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Rapid Diagnostics, Inc.

USA · Burlingame

✓ 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

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 3Class II 2Class III 0unclassified 1

plus 24 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 5Class II 4

20 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

18 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 States24 registration records, 5 510(k), 0 PMA, 29 excluded

Brazil9 confirmed, 6 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada3 confirmed, 5 excluded

Manufacturer names merged into this page: BD Rapid Diagnostics (Suzhou) Co. Ltd. · ABBOTT RAPID DIAGNOSTICS ULC · RAPID DIAGNOSTICS, DIVISION OF LUMIQUICK DIAGNOSTICS INC. · ABBOTT RAPID DIAGNOSTICS JENA GMBH

FDA 510(k) clearances by year

11998 · K981770

12001 · K003809

12002 · K020716

12004 · K033566

12017 · K171650

FDA listed device types

Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings 1Devices Detecting Influenza A, B, And C Virus Antigens 1Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Antigens, All Groups, Streptococcus Spp. 1Covid-19 Multi-Analyte Antigen Device 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K171650	Alere Afinion HbA1c and ACR on Afinion 2 analyzer	2017-11-21
US	K033566	MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062	2004-05-17
US	K020716	RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)	2002-05-06
BR	10071779007	Safety Lancet Super	Class II
BR	10071770934	Curativo adesivo - Penso adesivo	Class I
BR	10071770935	Sistema de coleta de sangue capilar	Class I
CA	86471	CLEARVIEW MONO	Class II
CA	86473	HCG COMBO CASSETTE 20/10	Class II
CA	86474	CLEARVIEW H.PYLORI	Class II

Rapid 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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