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IMMCO DIAGNOSTICS, INC.

USA · Buffalo

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Israel, Russia — 8 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

19listed device types

Class I 8Class II 11Class III 0

plus 27 registration records and 55 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

29registered devices

Class II 29

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

77active device licences

Class II 77

141 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 2 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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 States27 registration records, 55 510(k), 0 PMA

Brazil29 confirmed, 0 excluded

Canada77 confirmed, 0 excluded

Manufacturer names merged into this page: IMMCO DIAGNOSTICS, INC.

FDA 510(k) clearances by year

41992

21993

21994

41995

21996

31997

11998

11999

32003

42004

12006

12007

62010

12011

12012

12013

22015

12016

32017

22018

FDA listed device types

showing 8 of 19

Antinuclear Antibody, Antigen, Control 1Autoantibodies, Endomysial(Tissue Transglutaminase) 1Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) 1Extractable Antinuclear Antibody, Antigen And Control 1Reagent, Borrelia Serological Reagent 1System, Test, Rheumatoid Factor 1Anti-Sm Antibody, Antigen And Control 1Test System, Antineutrophil Cytoplasmic Antibodies (Anca) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K172745	ImmuGlo HEp-2 Elite IFA	2018-06-05
US	K172078	ImmuLisa Enhanced RNA POL III Antibody ELISA	2018-03-30
US	K163133	ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA	2017-08-08
BR	80944340028	ImmuGlo HEp-2 Elite IFA	Class II
BR	80944340029	ImmuLisa Celiac G+ IgG	Class II
BR	80944340030	ImmuGlo HEp-2 Cells Anti Nuclear Antibody IFA Kit	Class II
CA	85241	IMMULISA PR3 ANTIBODY ELISA	Class II
CA	85243	IMMULISA ENHANCED ACA ELISAS (IGG)	Class II
CA	85334	IMMULISA MPO ANTIBODY ELISA	Class II

IMMCO 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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