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Immuno Concepts, Inc.

USA · Sacramento

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

13listed device types

Class I 4Class II 9Class III 0

plus 35 registration records and 40 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 1Class II 7

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

5active device licences

Class II 5

14 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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, 40 510(k), 0 PMA, 16 excluded

Brazil8 confirmed, 0 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: IMMUNO CONCEPTS, NA, Ltd. · IMMUNO CONCEPTS N.A., LTD · IMMUNO CONCEPTS N.A.,LTD · IMMUNO CONCEPTS N.A.,LTD.

FDA 510(k) clearances by year

21981

11983

11984

21986

41988

61989

31991

11993

21994

11995

51996

41998

11999

32001

12003

12016

12018

12023

FDA listed device types

showing 8 of 13

Antinuclear Antibody, Antigen, Control 1System, Test, Anticardiolipin Immunological 1Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls 1Anti-Dna Indirect Immunofluorescent Solid Phase 1Extractable Antinuclear Antibody, Antigen And Control 1Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use 1Test System, Antineutrophil Cytoplasmic Antibodies (Anca) 1Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K203599	Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System	2023-05-26
US	K180202	Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts	2018-10-19
US	K160265	Image Navigator by Immuno Concepts	2016-06-17
BR	80213250004	RELISA ANA (SCREENING TEST)	Class II
BR	10300390634	HEP-2000 ANA-RO	Class II
BR	10300390767	IMAGE NAVIGATOR®	Class I
CA	61468	AUTO I.D. AUTOANTIBODY TEST	Class II
CA	61536	RELISA PR3 TEST SYSTEM	Class II
CA	61538	RELISA CARDIOLIPIN SCREENING TEST SYSTEM	Class II

Immuno Concepts, 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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