Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183608

FEI Number

2183608

Entity Name

Immucor GTI Diagnostics, Inc.

City/State/Country

Waukesha, WI, US

Establishment Address

20925 Crossroads Cir, Waukesha, WI 53186, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IMMUCOR, INC. (Owner Number: 1034569)

Owner / Operator Contact Address

3130 GATEWAY DR., Norcross, GA 30071, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK110011

PMA Number

N/A

All Registered Proprietary Names

LIFECODES HLA-NULL Allele SSO Typing Kit LIFECODES LSA Class I LIFECODES C3d Detection LIFECODES LSA Class II PF4 Enhanced assay MatchX LIFECODES LifeScreen XP LIFECODES HLA-DQB1 SSO Typing Kit LIFECODES HLA-B eRES SSO Typing Kit LIFECODES HLA-A eRES SSO Typing Kit LIFECODES HLA-DRB1 SSO Typing Kit LIFECODES HLA-A SSO Typing Kit LIFECODES HLA-C eRES SSO Typing Kit LIFECODES HLA-B SSO Typing Kit LIFECODES HLA-DRB 3,4,5 SSO Typing Kit LIFECODES HLA-DRB1 eRES SSO Typing Kit LIFECODES LifeScreen Deluxe LIFECODES Serum Cleaner Streptavidin-PE (SAPE) LIFECODES Taq Polymerase MATCH IT! Antibody THROMBOTYPE 1 (HPA 1) LIFECODES LSA Class I Factor VIII Antibody Screen DonorScreen-HLA Class I and Class II Additional Reagents DonorScreen-HLA Class I and Class II Concentrated Wash (10X) PakPlus® Assay LIFECODES ID Class IIv2: Luminex 100 screening assay for qualitative detection of IgG panel reactive antibodies (PRA)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MZI	Test, Qualitative, For Hla, Non-Diagnostic	Unknown	Class U	N/A	2015-02-26
LCO	Platelet Factor 4 Radioimmunoassay	Hematology	Class 2	864.7695	2020-09-17
MZI	Test, Qualitative, For Hla, Non-Diagnostic	Unknown	Class U	N/A	2025-09-22
MZI	Test, Qualitative, For Hla, Non-Diagnostic	Unknown	Class U	N/A	2022-10-17
MZI	Test, Qualitative, For Hla, Non-Diagnostic	Unknown	Class U	N/A	2014-08-27
MZI	Test, Qualitative, For Hla, Non-Diagnostic	Unknown	Class U	N/A	2016-08-04
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2013-04-15
MZI	Test, Qualitative, For Hla, Non-Diagnostic	Unknown	Class U	N/A	2022-10-17
MYP	Test, Platelet Antibody	Unknown	Class 2	N/A	2013-04-15
MZI	Test, Qualitative, For Hla, Non-Diagnostic	Unknown	Class U	N/A	2021-12-13
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2013-04-15
MZI	Test, Qualitative, For Hla, Non-Diagnostic	Unknown	Class U	N/A	2018-07-30
MYP	Test, Platelet Antibody	Unknown	Class 2	N/A	2015-07-06
MZI	Test, Qualitative, For Hla, Non-Diagnostic	Unknown	Class U	N/A	2013-04-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IMMUCOR, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1034569	IMMUCOR, INC.	Norcross, GA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972288	Universal Reagents, Inc.	FACTOR DEFICIENT PLASMAS - FACTOR IX (9)	1997-07-14
K010379	Instrumentation Laboratory CO	IL TEST FREE PROTEIN S	2001-04-13
K033631	Instrumentation Laboratory CO	MODIFICATION TO COATEST FACTOR VIII	2003-12-15
K924884	Instrumentation Laboratory CO	IL TEST(TM) PRO-CHROM	1993-01-14
K042576	Instrumentation Laboratory CO	COATEST SP FVIII	2004-12-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0736-2016	Instrumentation Laboratory Co.	2	HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Z-1519-2012	Instrumentation Laboratory Co.	2	Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183608. Last updated year: 2026. Please use registration number 2183608 when referencing this establishment in official correspondence.