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ABBOTT MOLECULAR, INC.

USA · Des Plaines

✓ 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

46listed device types

Class I 12Class II 25Class III 6unclassified 3

plus 105 registration records and 19 510(k), 244 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

31registered devices

Class I 27Class II 4

62 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

49 including historic records

TWTaiwanTFDA

55valid device licences

Class I 24Class II 19Class III 12

SGSingaporeHSA SMDR

32device registrations

CLASS B 3CLASS C 24CLASS D 5

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

IVD import 3

AUAustraliaTGA ARTG

19active ARTG entries

IVD Class 1 4IVD Class 2 1IVD Class 3 12IVD Class 4 2

HKHong KongMDACS

24valid listings

IVD B 4IVD C 17IVD D 3

ILIsraelAMAR

22registrations

RURussiaRoszdravnadzor

34active registrations

Class 2a 9Class 2b 9Class 3 16

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 States105 registration records, 19 510(k), 244 PMA, 27 excluded

Brazil31 confirmed, 10 excluded

Canada1 confirmed, 6 excluded

Manufacturer names merged into this page: ABBOTT MOLECULAR, INC. · Abbott Molecular Distribution Center · ABBOTT MOLECULAR INC. · ABBOTT MOLECULAR INC · ABBOTT MOLECULAR

FDA 510(k) clearances by year

12008

22010

22011

22013

12014

22022

12023

22024

62025

FDA listed device types

showing 8 of 46

Urine Transport Kit (Excludes Hiv Testing) 1Cells, Animal And Human, Cultured 1Device, Specimen Collection 1Dna Probe, Nucleic Acid Amplification, Chlamydia 1Clinical Sample Concentrator 1Stainer, Tissue, Automated 1Reagents, Specific, Analyte 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252102	Alinity m HCV	2025-09-25
US	K243489	Alinity m EBV (09N43-095)	2025-07-28
US	K243485	Alinity m CMV	2025-07-01
BR	80146502400	Família Alinity m Specimen Buffer	Class I
BR	80146509035	ABBOTT VP2000 PROCESSOR	Class II
BR	80146502414	simpli-Collect HPV Collection Kit	Class I
CA	93174	IMDX FLU A/B AND RSV FOR ABBOTT M2000	Class III