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Immucor GTI Diagnostics, Inc.

USA · Waukesha

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

5listed device types

Class I 1Class II 3Class III 0unclassified 1

plus 20 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 9Class II 1

13 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

11active device licences

Class II 8Class III 3

23 including historic records

TWTaiwanTFDA

14valid device licences

Class II 14

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

14active ARTG entries

IVD Class 2 4IVD Class 3 10

HKHong KongMDACS

6valid listings

IVD C 6

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 1Class 2b 3

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 States20 registration records, 2 510(k), 0 PMA, 2 excluded

Brazil10 confirmed, 3 excluded

Canada11 confirmed, 1 excluded

Manufacturer names merged into this page: Immucor GTI Diagnostics, Inc. · IMMUCOR GTI DIAGNOSTICS, INC. · IMMUCOR GTI DIAGNOSTICS, INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K201570	PF4 Enhanced assay	2020-09-11
US	K201311	PF4 IgG assay	2020-06-18
BR	80003610625	MATCH IT! Antibody	Class I
BR	80003610626	MATCH IT! Platelet Antibody	Class I
BR	80391910012	Match it! plaquetas	Class I
CA	61214	PLATELET ANTIGEN TYPING KIT	Class II
CA	61215	MODIFIED ANTIGEN CAPTURE ELISA (DETECTION OF IGG PLATELET ANTIBODIES)	Class II
CA	61216	FVIII INHIBITOR ASSAY	Class II

Immucor GTI 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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