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Standard Diagnostics, Inc.

Korea, Republic · Yongin-Si

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Israel, Russia — 5 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

28listed device types

Class I 12Class II 16Class III 0

plus 62 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class II 13

19 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

31 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

11active registrations

Class 1 1Class 2a 3Class 2b 5Class 3 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 States62 registration records, 18 510(k), 0 PMA, 24 excluded

Brazil13 confirmed, 3 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada2 confirmed, 3 excluded

Manufacturer names merged into this page: GOLD STANDARD DIAGNOSTICS, LLC · Gold Standard Diagnostics Frankfurt GmbH · STANDARD DIAGNOSTICS, INC. · GOLD STANDARD DIAGNOSTICS KASSEL GMBH · GOLD STANDARD DIAGNOSTICS FRANKFURT GMBH · GOLD STANDARD DIAGNOSTICS, LLC.

FDA 510(k) clearances by year

12003

12009

12010

42012

22014

12015

12018

22020

42021

12025

FDA listed device types

showing 8 of 28

Epstein-Barr Virus, Other 1Antigen, Fluorescent Antibody Test, Schistosoma Mansoni 1Antiserum, Cf, Epstein-Barr Virus 1Reagents, Cysticercosis 1Reagents, Specific, Analyte 1Elisa, Trichinella Spiralis 1Enzyme Linked Immunoabsorbent Assay, Mumps Virus 1General Purpose Reagent 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250249	Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System	2025-10-10
US	K203289	Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit	2021-03-22
US	K203295	Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit	2021-03-22
BR	80464810914	IgG Screen Nutritional 88 ELISA	Class II
BR	80464810915	IgG4 Screen Nutritional 88 ELISA	Class II
BR	80464810832	Helicobacter pylori IgM ELISA	Class II
CA	31493	HCG ONE STEP TEST CASSETTES	Class II
CA	91888	THUNDERBOLT	Class II

Standard Diagnostics, Inc.

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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