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LGC Clinical Diagnostics, Inc.

USA · Milford

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Israel — 6 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

9listed device types

Class I 5Class II 4Class III 0

plus 35 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class III 1Class IV 3

35 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

16device registrations

CLASS B 12CLASS C 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

16active ARTG entries

IVD Class 2 16

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States35 registration records, 0 510(k), 0 PMA

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: LGC Clinical Diagnostics, Inc. · LGC CLINICAL DIAGNOSTICS, INC.

FDA listed device types

showing 8 of 9

Multi-Analyte Controls, All Kinds (Assayed) 1Multi-Analyte Controls Unassayed 1Whole Blood Plasma, Antigen, Antiserum, Control 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Kit, Serological, Positive Control 1Kit, Quality Control For Blood Banking Reagents 1Antibody Igm,If, Cytomegalovirus Virus 1Kit, Test (Donors), For Bloodborne Pathogen 1

Market	Identifier	Name	Class / date
CA	99063	ACCURUN CMV DNA TRI-LEVEL CONTROLS	Class III
CA	99137	ACCURUN HIV RNA TRI-LEVEL CONTROLS	Class IV
CA	99149	ACCURUN HBV DNA TRI-LEVEL CONTROLS	Class IV

LGC Clinical Diagnostics, Inc.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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