Home›USA›LINCOLN DIAGNOSTICS, INC.

LINCOLN DIAGNOSTICS, INC.

USA · Decatur

✓ Record-verifiedregistrations found in 6 markets

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

1listed device types

Class I 0Class II 1Class III 0

plus 3 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

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

2active device licences

Class II 2

9 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States3 registration records, 2 510(k), 0 PMA, 3 excluded

Brazil5 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: LINCOLN DIAGNOSTICS, INC. · LINCOLN DIAGNOSTICS INC. · LINCOLN DIAGNOSTICS, INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K961918	MULTI-TEST II	1996-08-07
US	K941820	DUOTIP-TEST	1994-09-02
BR	81900289003	UniTest® PC	Class II
BR	10270099001	MULTI TEST II	Class II
BR	10270090003	DUOTIP - TEST® II	Class II
CA	1176	MULTI-TEST	Class II
CA	1185	DUOTIP TEST	Class II

LINCOLN 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)

Similar companies