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Abbott Diagnostics Scarborough, Inc.

USA · Scarborough

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

25listed device types

Class I 5Class II 17Class III 1unclassified 2

plus 42 registration records and 6 510(k), 18 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 1Class II 7

15 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class III 2

12 including historic records

TWTaiwanTFDA

12valid device licences

Class I 7Class II 5

SGSingaporeHSA SMDR

8device registrations

CLASS B 2CLASS C 6

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

14active ARTG entries

IVD Class 1 5IVD Class 2 4IVD Class 3 5

HKHong KongMDACS

5valid listings

IVD C 5

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 1Class 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 States42 registration records, 6 510(k), 18 PMA, 3 excluded

Brazil8 confirmed, 1 excluded

Canada2 confirmed, 1 excluded

Manufacturer names merged into this page: Abbott Diagnostics Scarborough, Inc. · ABBOTT DIAGNOSTICS SCARBOROUGH, INC. · ABBOTT DIAGNOSTICS SCARBOROUGH, INC

FDA 510(k) clearances by year

12019 · K191534

12022 · K220801

22023 · K232775

22025 · K250273

FDA listed device types

showing 8 of 25

Antisera, All Groups, Streptococcus Spp. 1Device, General Purpose, Microbiology, Diagnostic 1Kit, Direct Antigen, Positive Control 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus 1Cell Enzymes (Erythrocytic And Leukocytic) 1Human Metapneumovirus (Hmpv) Rna Assay System 1Respiratory Virus Panel Nucleic Acid Assay System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250273	BinaxNOW COVID-19 Ag Card	2025-06-13
US	K243518	BinaxNOW COVID-19 Antigen Self Test	2025-02-11
US	K232775	ID NOW Influenza A & B 2	2023-10-10
BR	10071770889	ID NOW RSV	Class II
BR	10071770846	ID NOW Instrument	Class II
BR	10071770887	Bioline Filariasis Test Strip	Class II
CA	104564	DIGIVAL	Class III
CA	104565	BINAXNOW INFLUENZA A & B CARD 2	Class III