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Abbott Diagnostics

USA · Mountain View

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

90listed device types

Class I 32Class II 54Class III 1unclassified 3

plus 121 registration records and 49 510(k), 18 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

199registered devices

Class I 32Class II 167

279 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

41active device licences

Class II 23Class III 11Class IV 7

198 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 States121 registration records, 49 510(k), 18 PMA, 56 excluded

Brazil199 confirmed, 22 excluded

Saudi Arabia1 confirmed, 1 excluded

Canada41 confirmed, 25 excluded

Manufacturer names merged into this page: ABBOTT IRELAND DIAGNOSTICS DIVISION · Abbott Diagnostics Korea Inc. · Abbott Diagnostics Scarborough, Inc. · Abbott Diagnostics (Shanghai) Co., Ltd. · ABBOTT LABORATORIES DIAGNOSTICS DIVISION · ABBOTT RAPID DIAGNOSTICS ULC

FDA 510(k) clearances by year

21981

21982

51983

31984

41985

11986

51987

21988

11989

11996

21997

11999

12017

22019

12021

82022

52023

12024

22025

FDA listed device types

showing 8 of 90

Kit, Test, Pregnancy, Hcg, Over The Counter 1Igm, Antigen, Antiserum, Control 1Alkaline Picrate, Colorimetry, Creatinine 1Bromcresol Purple Dye-Binding, Albumin 1Calibrator, Secondary 1Devices Detecting Influenza A, B, And C Virus Antigens 1Calibrator, Primary 1System, Test, Rheumatoid Factor 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	K240468	Alkaline Phosphatase	2024-10-16
BR	10055310843	PHOSPHORUS / FÓSFORO	Class II
BR	10055310845	GLUCOSE / GLICOSE	Class II
BR	10055310939	ICT SAMPLE DILUENT / ICT DILUENTE DE AMOSTRA	Class I
SA	ME0000002989SFDAA00176	flexitainer	—
CA	321	CELL-DYN 3200 SYSTEM	Class II
CA	1014	CELL-DYN 1300 SYSTEM	Class II
CA	1015	CELL-DYN 4000 SYSTEM	Class II

Abbott Diagnostics

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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