immucor.comTest, Qualitative, For HLA, Non-Diagnostic
Immucor GTI Diagnostics, Inc.
IMMUCOR, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1034569 | 1034569 | IMMUCOR, INC. | 1 | N | 2026-01-01 | 3130 GATEWAY DR. Norcross GA US 30071 |
| 2183608 | 2183608 | Immucor GTI Diagnostics, Inc. | 1 | N | 2026-01-01 | 20925 Crossroads Cir Waukesha WI US 53186 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10888234001027 | H.P.C. (Human Platelet Concentrate) - H.P.C. (Human Platelet Concentrate) is used to reduce or remove HLA (Bg) activity from serum as an aid in antibody detection and identification. H.P.C. is a dry preparation of a washed pool of platelets from individual human platelet donors. This product is a dry preparation which must be rehydrated before use. This product configuration has ten (10) vials. | 1-855-466-8267 | tech_support@immucor.com |
| 10888234400332 | LIFECODES LSA Class I - LIFECODES LSA Class I is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation. | 855-466-8267 | LIFECODES@immucor.com |
| 10888234400332 | LIFECODES LSA Class I - LIFECODES LSA Class I is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation. | 855-466-8267 | info@immucor.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 213 | 1268047793 | K910003 | CYTOMEGALOVIRUS ANTIBODY SCREEN | LJO | 1991-03-20 |
| 213 | 1682377112 | K813342 | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | KSK | 1982-03-04 |
| 213 | 1923210883 | K810803 | FREEZE DRIED PAPAIN | KSK | 1981-07-21 |
| 213 | 1675990588 | K802534 | GAMMA PI BLOOD GROUP SUBSTANCE | KSX | 1980-11-12 |
| 213 | 1609437791 | K802533 | GAMMA LEWIS BLOOD GROUP SUBSTANCE | KSX | 1980-11-12 |
| 213 | 1789049593 | K790973 | LO-ION | KSG | 1979-06-15 |
| 213 | 1651718010 | K203612 | Capture-CMV | LJO | 2021-03-22 |
| 157388 | 1594189916 | K201570 | PF4 Enhanced assay | LCO | 2020-09-11 |
| 157388 | 1285754493 | K201311 | PF4 IgG assay | LCO | 2020-06-18 |
| 157388 | 1069919947 | K082205 | FACTOR VIII ANTIBODY SCREEN | GGP | 2008-11-20 |
| 157388 | 1778387380 | K071781 | PF4 IGG | LCO | 2007-12-19 |
| 157388 | 2032947168 | K053559 | PF4 ENHANCED SOLID PHASE ELISA | LCO | 2006-01-20 |
| 157388 | 1013230897 | BK990043 | |||
| 213 | 1668926421 | BK960090 | |||
| 157388 | 1454019897 | BK960059 | |||
| 157388 | 2027731854 | BK950005 | |||
| 213 | 1306315314 | BK930023 | |||
| 213 | 1712951350 | BK910001 | |||
| 213 | 1413903097 | BK900021 | |||
| 213 | 1635466146 | BK880022 | |||
| 213 | 1743120380 | BK880016 | |||
| 213 | 1087346363 | BK880015 | |||
| 213 | 1332051044 | BK860024 | |||
| 157388 | 2009675529 | BK860022 | |||
| 213 | 1735895400 | BK860017 | |||
| 213 | 1140113139 | BK850008 | |||
| 213 | 1615336139 | BK830022 | |||
| 213 | 1811393822 | BK830018 | |||
| 213 | 1877500939 | BK830014 | |||
| 213 | 1153857805 | BK830013 | |||
| 213 | 1059617712 | BK830008 | |||
| 213 | 1360701952 | BK830004 | |||
| 213 | 1868549527 | BK251256 | |||
| 213 | 1809291678 | BK241080 | |||
| 157388 | 1978105858 | BK241067 | |||
| 213 | 2050568016 | BK230806 | |||
| 213 | 2010677326 | BK220779 | |||
| 157388 | 1163784791 | BK220763 | |||
| 157388 | 1737651261 | BK220762 | |||
| 213 | 1330225860 | BK220670 | |||
| 213 | 1328727119 | BK220669 | |||
| 213 | 1157859310 | BK210605 | |||
| 213 | 1842963951 | BK210600 | |||
| 157388 | 2053110238 | BK210574 | |||
| 157388 | 1326551437 | BK210573 | |||
| 157388 | 1453038098 | BK210572 | |||
| 213 | 1169429325 | BK210562 | |||
| 213 | 1020064221 | BK210560 | |||
| 213 | 1098145717 | BK200542 | |||
| 213 | 1109862554 | BK200502 | |||
| 213 | 1539252207 | BK200474 | |||
| 157388 | 1125556720 | BK190439 | |||
| 213 | 1978432311 | BK190337 | |||
| 213 | 1483990227 | BK180243 | |||
| 157388 | 1560591107 | BK180181 | |||
| 213 | 1199016628 | BK170135 | |||
| 213 | 1327003759 | BK170067 | |||
| 157388 | 2026486691 | BK160035 | |||
| 157388 | 1156388702 | BK150343 | |||
| 213 | 1701670532 | BK150333 | |||
| 157388 | 1670925812 | BK150302 | |||
| 157388 | 1310457465 | BK140163 | |||
| 157388 | 1459918908 | BK130075 | |||
| 213 | 1246021413 | BK110067 | |||
| 213 | 1228465467 | BK110050 | |||
| 157388 | 1996637584 | BK110011 | |||
| 213 | 1258345758 | BK070039 | |||
| 213 | 1099062856 | BK070016 | |||
| 213 | 1331192019 | BK070015 | |||
| 213 | 1571667560 | BK060016 | |||
| 157388 | 1264083165 | BK050040 | |||
| 157388 | 1398866560 | BK040035 | |||
| 213 | 1238409829 | BK040024 | |||
| 213 | 1081934743 | BK040014 | |||
| 213 | 1668265694 | BK040013 | |||
| 213 | 1285818046 | BK040010 | |||
| 213 | 1604333896 | BK020053 | |||
| 157388 | 1168336310 | ||||
| 213 | 1186830366 | ||||
| 213 | 1194499913 | ||||
| 157388 | 1326308070 | ||||
| 213 | 1385030008 | ||||
| 213 | 1408437373 | ||||
| 213 | 1551718347 | ||||
| 213 | 1570726338 | ||||
| 213 | 1654966688 |
Product Codes Associated With Registrations#
PMN#
Test, Qualitative, For HLA, Non-Diagnostic
Immucor GTI Diagnostics, Inc.
System, Test, Automated Blood Grouping And Antibody
Immucor, Inc.
System, Test, Automated Blood Grouping And Antibody
Immucor, Inc.
Capture-CMV
Immucor, Inc.
PF4 Enhanced Assay
Immucor GTI Diagnostics, Inc.
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
Immucor, Inc.
PF4 IgG Assay
Immucor GTI Diagnostics, Inc.
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
Immucor, Inc.
Qualitative Test For HLA, Non-diagnostic
Immucor GTI Diagnostics, Inc.
Automated Blood Grouping And Antibody Test Systems
Immucor, Inc.
Capture-CMV
Immucor, Inc.
CMV Tests For Donors
Immucor, Inc.
Automated Blood Grouping And Antibody Test Systems
Immucor, Inc.
Automated Blood Grouping And Antibody Test Systems
Immucor, Inc.
Qualitative Test For HLA, Non-diagnostic
Immucor GTI Diagnostics, Inc.
Automated Blood Grouping And Antibody Test Systems
Immucor, Inc.
Automated Blood Grouping And Antibody Test Systems
Immucor, Inc.
Automated Blood Grouping And Antibody Test Systems
Immucor, Inc.
Qualitative Test For HLA, Non-diagnostic
Immucor Transplant Diagnostics, Inc.
Qualitative Test For HLA, Non-diagnostic
Immucor Transplant Diagnostics, Inc.
Qualitative Test For HLA, Non-diagnostic
Immucor GTI Diagnostics, Inc.
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
Immucor, Inc.
Platelet Antibody Test
Immucor GTI Diagnostics, Inc.
Qualitative Test For HLA, Non-diagnostic
Immucor Transplant Diagnostics, Inc.
Qualitative Test For HLA, Non-diagnostic
Immucor GTI Diagnostics, Inc.
Test, Syphilis, Treponema (FOR DONOR TESTING)
Immucor, Inc.
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
Immucor, Inc.
Fetal Hemoglobin Assay
Immucor, Inc.
Quality Control Kits For Blood Banking Reagents
Immucor, Inc.
Automated Blood Grouping And Antibody Test Systems
Immucor, Inc.
Automated Blood Grouping And Antibody Test Systems
Immucor, Inc.
Automated Blood Grouping And Antibody Test Systems
Immucor, Inc.
Quality Control Kits For Blood Banking Reagents
Immucor, Inc.
Quality Control Kits For Blood Banking Reagents
Immucor, Inc.
Automated Blood Grouping And Antibody Test Systems
Immucor, Inc.
Kit, Quality Control For Blood Banking Reagents
Immucor, Inc.
Automated Blood Grouping And Antibody Test Systems
Immucor, Inc.
Quality Control Kits For Blood Banking Reagents
Immucor, Inc.
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
Immucor, Inc.
GUDID#
Capture LISS - Capture LISS for Capture-R Ready Screen (10X) is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%). The reagent will turn from blue purple to sky blue or turquoise in the presence of normal human serum or plasma.
2022-09-03
MatchX - MatchX Software is an accessory to aid in the evaluation of test results from Immucor GTI Diagnostics, Inc. LIFECODES® Antibody Detection kits and LIFECODES® HLA-SSO Typing kits for use with Luminex® instruments. Due to the complex nature of HLA Testing, qualified laboratory personnel must review any result to ensure correctness.
2025-09-30
H.P.C. (Human Platelet Concentrate) - H.P.C. (Human Platelet Concentrate) is used to reduce or remove HLA (Bg) activity from serum as an aid in antibody detection and identification. H.P.C. is a dry preparation of a washed pool of platelets from individual human platelet donors. This product is a dry preparation which must be rehydrated before use. This product configuration has ten (10) vials.
2016-04-18
ImmuLINK - ImmuLINK is middleware software that allows the user to link the application software database on automated (and/or semi-automated) blood bank instruments; the user may also link the instrument database(s) with the user’s Laboratory Information System (LIS). ImmuLINK is software designed to provide an interface between the user, blood bank instruments, and Blood Establishment Computer. ImmuLINK allows integration of sample, donor, or patient data that has been collected from multiple sources and provides data management tools to create customizable reports from the diverse data.
2024-12-05
PF4 Enhanced® - PF4 Enhanced assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies reactive with platelet factor 4 (PF4) when it is complexed to polyanionic compounds such as Polyvinyl Sulfonate (PVS). These antibodies are found in some patients undergoing heparin therapy.
2016-07-08
Dilution Solution - For Use with HLA-SSO Typing Kits
2020-05-20
LIFECODES LifeScreen XP - LIFECODES LifeScreen XP is a manual, qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class II molecules in patients sensitized to HLA by transfusion, pregnancy, or transplantation to aid donor and recipient match in transfusion or transplantation.
2023-07-11
LIFECODES LSA Class I - LIFECODES LSA Class I is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation.
2022-04-06
LIFECODES LSA Class II - LIFECODES LSA Class II is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation.
2022-04-06
LIFECODES MATCH IT! Antibody Software - 888627
2022-02-18
LIFECODES MATCH IT!™ DNA Software v1.3 - 888623
2020-02-26
LIFECODES HLA-A eRES SSO Typing Kit for use with Luminex - DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
2016-09-15
LIFECODES HLA-B eRES SSO Typing Kit for use with Luminex - DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
2016-09-15
LIFECODES HLA-C eRES SSO Typing Kit for use with Luminex - DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
2016-09-15
LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with Luminex - DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching
2016-09-15
LIFECODES HLA-DRB 3,4,5 SSO Typing Kit for use with Luminex - DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching
2016-09-15
LIFECODES TAQ Polymerase - 628075
2016-09-15
LIFECODES Class I ID Typing Kit for use with Luminex - LIFECODES Class I ID is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
2016-09-15
LIFECODES Class II IDv2 for use with Luminex - LIFECODES Class II IDv2 is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
2016-09-15
LIFECODES LifeScreen Deluxe - LIFECODES LifeScreen Deluxe is a qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class II molecules
2016-09-15
LIFECODES HLA-DQA1/B1 SSO Typing Kit for use with Luminex - DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching
2016-09-15
LIFECODES HLA-DPA1/B1 SSO Typing Kit for use with Luminex - DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching
2016-09-15
Conjugate Concentrate - For Use with LIFECODES LifeScreen Deluxe
2016-09-15
LIFECODES Wash Buffer - For Use with LIFECODES LifeScreen Deluxe
2016-09-15
Conjugate Concentrate - For Use with LIFECODES Class I ID and LIFECODES Class II IDv2
2016-09-15
Dilution Solution - For Use with HLA-SSO Typing Kits
2016-09-15
LIFECODES Fluoroanalyzer - 888302
2016-09-15
Factor VIII Antibody Screen - The Factor VIII Antibody Screen is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect reactive with recombinant human factor VIII (FVIII) in human serum and plasma.
2016-07-01
PF4 Enhanced® - PF4 Enhanced assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies reactive with platelet factor 4 (PF4) when it is complexed to polyanionic compounds such as Polyvinyl Sulfonate (PVS). These antibodies are found in some patients undergoing heparin therapy.
2016-07-01
PF4 IgG - PF4 IgG is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum.
2016-07-08
PF4 IgG - PF4 IgG is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum.
2016-07-08
DonorScreen-HLA® Class I and Class II Additional Reagents - DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors.
2016-07-08
DonorScreen-HLA® Class I and Class II - DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors.
2016-07-01
PakPlus® - The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet glycoprotein (GP) IV antigens, and to polymorphic epitopes on the platelet glycoproteins IIb/IIIa, Ib/IX, and Ia/IIa.
2016-07-08
ThromboType®1 - ThromboType 1 assay is an assay for the molecular determination of HPA-1 (PlA) using PCR amplification of human genomic DNA.
2016-07-08
Specimen Diluent - For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G)
2016-07-08
Anti-Human IgG Conjugate - For Use with PF4 IgG (HAT13G & HAT45G)
2016-07-08
Anti-Human IgG/A/M Conjugate - For Use with PF4 Enhanced (X-HAT13 & X-HAT45)
2016-07-08
Concentrated Wash (10X) - For Use with Factor VIII Antibody Screen and PakPlus
2016-07-08
Negative Serum Control - For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G)
2016-07-08