Immucor GTI Diagnostics, Inc.

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• immucor.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• Test, Qualitative, For HLA, Non-Diagnostic

  2022-09-29

  Immucor GTI Diagnostics, Inc.

• Test, Qualitative, For HLA, Non-Diagnostic

  2022-09-29

  Immucor GTI Diagnostics, Inc.

• PF4 Enhanced Assay

  2020-09-11

  Immucor GTI Diagnostics, Inc.

• PF4 IgG Assay

  2020-06-18

  Immucor GTI Diagnostics, Inc.

• Qualitative Test For HLA, Non-diagnostic

  2020-01-21

  Immucor GTI Diagnostics, Inc.

• Qualitative Test For HLA, Non-diagnostic

  2018-06-14

  Immucor GTI Diagnostics, Inc.

• Qualitative Test For HLA, Non-diagnostic

  2016-04-21

  Immucor GTI Diagnostics, Inc.

• Platelet Antibody Test

  2015-04-27

  Immucor GTI Diagnostics, Inc.

• Qualitative Test For HLA, Non-diagnostic

  2013-09-23

  Immucor GTI Diagnostics, Inc.

GUDID#

• 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.

  IMMUCOR GTI DIAGNOSTICS, INC.

  2025-09-30

• Dilution Solution - For Use with HLA-SSO Typing Kits

  IMMUCOR GTI DIAGNOSTICS, INC.

  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.

  IMMUCOR GTI DIAGNOSTICS, INC.

  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.

  IMMUCOR GTI DIAGNOSTICS, INC.

  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.

  IMMUCOR GTI DIAGNOSTICS, INC.

  2022-04-06

• LIFECODES MATCH IT! Antibody Software - 888627

  IMMUCOR GTI DIAGNOSTICS, INC.

  2022-02-18

• LIFECODES MATCH IT!™ DNA Software v1.3 - 888623

  IMMUCOR GTI DIAGNOSTICS, INC.

  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

  IMMUCOR GTI DIAGNOSTICS, INC.

  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

  IMMUCOR GTI DIAGNOSTICS, INC.

  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

  IMMUCOR GTI DIAGNOSTICS, INC.

  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

  IMMUCOR GTI DIAGNOSTICS, INC.

  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

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-09-15

• LIFECODES TAQ Polymerase - 628075

  IMMUCOR GTI DIAGNOSTICS, INC.

  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)

  IMMUCOR GTI DIAGNOSTICS, INC.

  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)

  IMMUCOR GTI DIAGNOSTICS, INC.

  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

  IMMUCOR GTI DIAGNOSTICS, INC.

  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

  IMMUCOR GTI DIAGNOSTICS, INC.

  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

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-09-15

• Conjugate Concentrate - For Use with LIFECODES LifeScreen Deluxe

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-09-15

• LIFECODES Wash Buffer - For Use with LIFECODES LifeScreen Deluxe

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-09-15

• Conjugate Concentrate - For Use with LIFECODES Class I ID and LIFECODES Class II IDv2

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-09-15

• Dilution Solution - For Use with HLA-SSO Typing Kits

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-09-15

• LIFECODES Fluoroanalyzer - 888302

  IMMUCOR GTI DIAGNOSTICS, INC.

  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.

  IMMUCOR GTI DIAGNOSTICS, INC.

  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.

  IMMUCOR GTI DIAGNOSTICS, INC.

  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.

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-07-08

• PF4 IgG - PF4 IgG is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum.

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-07-08

• PF4 IgG - PF4 IgG is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum.

  IMMUCOR GTI DIAGNOSTICS, INC.

  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.

  IMMUCOR GTI DIAGNOSTICS, INC.

  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.

  IMMUCOR GTI DIAGNOSTICS, INC.

  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.

  IMMUCOR GTI DIAGNOSTICS, INC.

  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.

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-07-08

• Specimen Diluent - For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G)

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-07-08

• Anti-Human IgG Conjugate - For Use with PF4 IgG (HAT13G & HAT45G)

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-07-08

• Anti-Human IgG/A/M Conjugate - For Use with PF4 Enhanced (X-HAT13 & X-HAT45)

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-07-08

• Concentrated Wash (10X) - For Use with Factor VIII Antibody Screen and PakPlus

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-07-08

• Negative Serum Control - For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G)

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-07-08

• PF4 Concentrated Wash (10x) - For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G)

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-07-08

• Positive Serum Control - For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G)

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-07-08

• Concentrated Wash (10X) - For Use with DonorScreen-HLA Class I and Class II

  IMMUCOR GTI DIAGNOSTICS, INC.

  2016-07-08

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