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Diasorin Molecular, LLC

USA · Cypress

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, 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

41listed device types

Class I 16Class II 21Class III 2unclassified 2

plus 50 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

18registered devices

Class I 7Class II 11

30 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

17active device licences

Class II 10Class III 7

109 including historic records

TWTaiwanTFDA

5valid device licences

Class I 5

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

IVD Class 1 1IVD Class 2 3IVD Class 3 8

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 States50 registration records, 15 510(k), 0 PMA, 9 excluded

Brazil18 confirmed, 10 excluded

Canada17 confirmed, 2 excluded

Manufacturer names merged into this page: DiaSorin Molecular LLC · DIASORIN MOLECULAR LLC

FDA 510(k) clearances by year

12017

42018

22019

12020

22022

12023

12024

22025

12026

FDA listed device types

showing 8 of 41

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg 1Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm 1C. Difficile Nucleic Acid Amplification Test Assay 1Antiserum, Fluorescent, Q Fever 1Device, General Purpose, Microbiology, Diagnostic 1Internal Polymerase Chain Reaction Control, Not Assay Specific 1Antiserum, Typhus Fever 1Reagents, Specific, Analyte 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260333	LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit	2026-06-15
US	K251978	LIAISON NES FLU A/B, RSV & COVID-19	2025-12-23
US	K252387	Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)	2025-10-30
BR	10339840495	Simplexa Extraction & Amplification Control Set	Class II
BR	10339840496	Simplexa Spectral Calibration Panel	Class I
BR	10339840498	Simplexa Extraction & Amplification Control Set - RNA	Class I
CA	4237	LYME DISEASE IFA IGM	Class II
CA	6370	LYME DISEASE IFA IGG	Class II
CA	6374	LYME DISEASE ELISA IGM	Class II

Diasorin Molecular, LLC

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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