IMMUCOR, INC.

FDA Device Registration & Listing · Norcross, GA, US · Registration 1034569

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1034569
FEI Number
1034569
Entity Name
IMMUCOR, INC.
City/State/Country
Norcross, GA, US
Establishment Address
3130 GATEWAY DR., Norcross, GA 30071, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
IMMUCOR, INC. (Owner Number: 1034569)
Owner / Operator Contact Address
3130 GATEWAY DR., Norcross, GA 30071, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
BK210601
PMA Number
N/A

All Registered Proprietary Names

FMH RapidScreen Blood Bank Droppers ImmuLINK FDP (Freeze Dried Papain) Galileo QC Cell Segment Sampler Weak D Cells Galileo Echo Rh-Hr Control PHIX WB corQC Capture-P Test System W.A.R.M. Capture-R Select Capture Positive Control Cell (Component of Capture-R Ready-Screen (3) and Ready-ID) Checkcell Checkcell (Weak) DAT Positive Control Cell NEO Iris Galileo NEO Iris Capture-CMV Anti-H Lectin Gamma EGA Kit Complement Control Cells corQC EXTEND Gamma N-HANCE GammaZyme-B GammaZyme-F (BK870014/BK870041) RESt (Rabbit Erythrocyte Stroma) Gamma-clone Control Capture-P Ready Screen Test System Gamma LO-ION Galileo NEO P1 Blood Group Substance Gamma ELU-Kit II Bovine Albumin 22% ImmuAdd ImmuLINK (v3.2) NEO Iris Echo Lumena Capture-R Ready Indicator Red Cells Red Blood Cell (RBC) Storage Solution ImmuLINK (v3.3) Galileo Neo NEO Iris Galileo Neo (v3.1) Galileo Neo Gamma-Quin Galileo Neo Echo Lumena

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LIM Test, Screening, For D Positive Fetal Rbc'S Hematology Class 2 864.7455 2012-06-27
JRC Micro Pipette Clinical Chemistry Class 1 862.2050 2008-10-22
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2017-11-01
KSK Solution, Stabilized Enzyme Hematology Class 2 864.9400 2008-03-13
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2008-03-12
KSS Supplies, Blood-Bank Hematology Class 1 864.9050 2002-12-17
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2008-03-12
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2026-06-16
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2008-03-12
JCC Ph Buffer Pathology Class 1 864.4010 1994-01-26
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2008-03-12
KSS Supplies, Blood-Bank Hematology Class 1 864.9050 2008-04-07
KSK Solution, Stabilized Enzyme Hematology Class 2 864.9400 2008-03-12
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2008-03-13
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2023-05-11
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2012-03-08
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2018-12-04
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2008-03-12
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2021-12-28
LJO Antigen, Iha, Cytomegalovirus Microbiology Class 2 866.3175 2008-03-31
KSI Lectins And Protectins Hematology Class 2 864.9550 2008-03-17
KSG Media, Potentiating For In Vitro Diagnostic Use Hematology Class 2 864.9600 1977-12-06
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2008-03-12
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2008-03-12
KSG Media, Potentiating For In Vitro Diagnostic Use Hematology Class 2 864.9600 1977-12-06
KSK Solution, Stabilized Enzyme Hematology Class 2 864.9400 2002-12-17
LSQ Reagent, Rickettsia Serological Microbiology Class 1 866.3500 1999-10-22
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 1977-12-06
KSS Supplies, Blood-Bank Hematology Class 1 864.9050 2008-04-07
KSG Media, Potentiating For In Vitro Diagnostic Use Hematology Class 2 864.9600 2008-03-31
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2022-08-10
KSX Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use Hematology Class 2 864.9160 2002-12-17
KSG Media, Potentiating For In Vitro Diagnostic Use Hematology Class 2 864.9600 1977-12-06
KSG Media, Potentiating For In Vitro Diagnostic Use Hematology Class 2 864.9600 2008-03-12
KSG Media, Potentiating For In Vitro Diagnostic Use Hematology Class 2 864.9600 2008-03-12
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2024-08-13
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2022-08-10
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2018-05-25
KSF Kit, Quality Control For Blood Banking Reagents Hematology Class 2 864.9650 2008-03-13
GIF Diluent, Blood Cell Hematology Class 1 864.8200 2006-04-05
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2026-02-19
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2017-11-01
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2021-12-28
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2021-01-26
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2021-12-28
KSK Solution, Stabilized Enzyme Hematology Class 2 864.9400 2008-03-13
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2021-12-28
KSZ System, Test, Automated Blood Grouping And Antibody Hematology Class 2 864.9175 2026-06-16

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
2183608 Immucor GTI Diagnostics, Inc. Waukesha, WI, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1034569. Last updated year: 2026. Please use registration number 1034569 when referencing this establishment in official correspondence.
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