This page includes the latest FDA filings for Immucor Gti Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 2183608 |
| FEI Number | 2183608 |
| Name | Immucor GTI Diagnostics, Inc. |
| Owner & Operator | IMMUCOR, INC. |
| Contact Address | 3130 GATEWAY DR. Norcross GA 30071 US |
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 20925 Crossroads Cir Waukesha, WI 53186 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| IMMUCOR GTI DIAGNOSTICS, INC. | Dilution Solution 628515UDI | 2023-07-31 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES LifeScreen XP 628220 | 2023-07-19 |
Immucor GTI Diagnostics, Inc. | 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. | LIFECODES LSA Class II 265200IVD | 2022-04-14 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES LSA Class I 265100IVD | 2022-04-14 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES MATCH IT! Antibody Software v1.4 888627 | 2022-02-28 |
Immucor GTI Diagnostics, Inc. | PF4 Enhanced Assay | 2020-09-11 |
Immucor GTI Diagnostics, Inc. | PF4 IgG Assay | 2020-06-18 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES MATCH IT!™ DNA Software v1.3 888623 | 2020-03-05 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | MATCH IT! DNA (version 1.3) | 2020-02-13 |
Immucor GTI Diagnostics, Inc. | Qualitative Test For HLA, Non-diagnostic | 2020-01-21 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES® QuikScreen® QS12G | 2019-12-16 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES® B-Screen® BCSG | 2019-12-16 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Dilution Solution 628155 | 2019-01-10 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Negative Control Serum 403887 | 2019-01-10 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Positive Control Serum 403892 | 2019-01-10 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Negative Control Serum 628209 | 2019-01-10 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Positive Control Serum 628208 | 2019-01-10 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES Wash Buffer 628221 | 2019-01-10 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Negative Control Serum 628214 | 2019-01-10 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Positive Control Serum 628213 | 2019-01-10 |
| IMMUCOR GTI DIAGNOSTICS, INC. | ThromboType® THROMBOTYPE | 2018-08-15 |
| IMMUCOR GTI DIAGNOSTICS, INC. | PNPP Substrate 403594 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Positive Serum Control 404601 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Positive Serum Control 404600 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Positive Serum Control 404598 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Positive Serum Control 404597 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Positive Serum Control 404596 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Cell Resuspension and Preservative Solution 404590 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Anti-Human IgG/A/M Conjugate 404589 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Negative Serum Control 404577 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Negative Serum Control 404576 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Negative Serum Control 404574 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Negative Serum Control 404573 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Negative Serum Control 404572 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Eluting Solution 404565 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Buffering Solution 404560 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Anti-Human IgG Conjugate 404558 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Anti-Human IgG Conjugate 404557 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Specimen Diluent 403831 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Substrate Buffer 403613 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Stopping Solution 403603 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Positive Control 403596 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Negative Control 403593 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Kit Control 403591 | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Pak2-LE PAK2-LE | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Pak12®G PAK12G | 2018-08-01 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Pak12® PAK12 | 2018-08-01 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | DonorScreen-HLA Class I and Class II | 2018-07-30 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | DonorScreen-HLA Class I and Class II Additional Reagents | 2018-07-30 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | Concentrated Wash (10X) | 2018-07-30 |
| IMMUCOR GTI DIAGNOSTICS, INC. | PakAuto® PAKAUTO-MAYO | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | PakPlus® PAKPLUS100 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | 3 x 4% E-Gel 48 Gels EGEL48 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Anti-Human IgG/A/M Conjugate 404588 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Positive Platelet Control (Positive Eluate Control 404579 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Normal Platelet Control (Negative Eluate Control) 404578 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Concentrated Wash (10X) 404563 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Positive Serum Control 403625 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | PF4 Concentrated Wash (10x) 403624 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Negative Serum Control 403623 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Concentrated Wash (10X) 403622 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Anti-Human IgG/A/M Conjugate 403619 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Anti-Human IgG Conjugate 403618 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Specimen Diluent 403602 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | ThromboType®1 THROMBOTYPE1 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | PakPlus® PAKPLUS | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | PakAuto® PAKAUTO | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | DonorScreen-HLA® Class I and Class II DSI+II | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | DonorScreen-HLA® Class I and Class II Additional R 303456 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | PF4 IgG HAT45G | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | PF4 IgG HAT13G | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | PF4 Enhanced® X-HAT45 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | PF4 Enhanced® X-HAT13 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Factor VIII Antibody Screen F8S | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES Fluoroanalyzer 888302 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Dilution Solution 628515 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Conjugate Concentrate 628201 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES Wash Buffer 628211 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Conjugate Concentrate 628212 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES HLA-DPA1/B1 SSO Typing Kit for use with 628936 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES HLA-DQA1/B1 SSO Typing Kit for use with 628930 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES MATCH IT!™ DNA Software v1.2 888623 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES LifeScreen Deluxe 628215 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES Class II IDv2 for use with Luminex 628223 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES Class I ID Typing Kit for use with Lumin 628200 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES TAQ Polymerase 628075 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES HLA-DRB 3,4,5 SSO Typing Kit for use wit 628927 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES HLA-DRB1 eRES SSO Typing Kit for use wi 628925 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES HLA-DRB1 SSO Typing Kit for use with Lum 628923 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES HLA-C eRES SSO Typing Kit for use with 628921 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES HLA-B eRES SSO Typing Kit for use with 628917 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES HLA-B SSO Typing Kit for use with Lumin 628915 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES HLA-A eRES SSO Typing Kit for use with L 628913 | 2018-07-06 |
| IMMUCOR GTI DIAGNOSTICS, INC. | LIFECODES HLA-A SSO Typing Kit 628911 | 2018-07-06 |
Immucor GTI Diagnostics, Inc. | Qualitative Test For HLA, Non-diagnostic | 2018-06-14 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Substrate Buffer 404587 | 2018-03-29 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Specimen Diluent 404582 | 2018-03-29 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Stopping Solution 404585 | 2018-03-29 |
| IMMUCOR GTI DIAGNOSTICS, INC. | Concentrated Wash (10X) 404562 | 2018-03-29 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES LifeScreen Deluxe | 2016-08-04 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES MATCH IT! DNA Software v1.2 | 2016-06-16 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES HLA-DQA1/B1 SSO Typing Kit | 2016-06-16 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES HLA-DPA1/B1 SSO Typing Kit | 2016-06-16 |
Immucor GTI Diagnostics, Inc. | Qualitative Test For HLA, Non-diagnostic | 2016-04-21 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | PakPlus? Assay | 2015-07-06 |
Immucor GTI Diagnostics, Inc. | Platelet Antibody Test | 2015-04-27 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES LSA Class II | 2015-02-26 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES LSA Class I | 2015-02-26 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES HLA-NULL Allele SSO Typing Kit | 2015-02-26 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES C3d Detection | 2015-02-26 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES HLA-DRB1 eRES SSO Typing Kit | 2014-08-27 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES HLA-DRB1 SSO Typing Kit | 2014-08-27 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES HLA-DRB 3,4,5 SSO Typing Kit | 2014-08-27 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES HLA-DQB1 SSO Typing Kit | 2014-08-27 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES HLA-C eRES SSO Typing Kit | 2014-08-27 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES HLA-B eRES SSO Typing Kit | 2014-08-27 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES HLA-B SSO Typing Kit | 2014-08-27 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES HLA-A eRES SSO Typing Kit | 2014-08-27 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES HLA-A SSO Typing Kit | 2014-08-27 |
Immucor GTI Diagnostics, Inc. | Qualitative Test For HLA, Non-diagnostic | 2013-09-23 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | Factor VIII Antibody Screen | 2013-04-15 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | PF4 IgG | 2013-04-15 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | PF4 Enhanced Solid Phase ELISA | 2013-04-15 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | Solid Phase ELISA Assay for Detection of IgG Antibodies to HLA Class II Antigens | 2013-04-15 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | B-SCREEN | 2013-04-15 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | PAKAUTO Platelet Antibody Screening Kit | 2013-04-15 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | QUIKSCREEN | 2013-04-15 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | GTI-HLA 1, Class I Antibody Screening Kit | 2013-04-15 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | HLA Typing Trays GTI-DR HLA Typing Trays | 2013-04-15 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES ID Class IIv2: Luminex 100 screening assay for qualitative detection of IgG panel reactive antibodies (PRA) | 2013-04-15 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | THROMBOTYPE 1 (HPA 1) | 2013-04-15 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES ID Class I: Luminex 100 screening assay for detection of IgG panel reactive antibodies (PRA) | 2013-04-15 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | Streptavidin-PE (SAPE) | 2013-04-15 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES Taq Polymerase | 2013-04-15 |
Immucor GTI Diagnostics, Inc. [IMMUCOR, INC.] | LIFECODES Serum Cleaner | 2013-04-15 |
| NCAGE Code | 49MF6 | IMMUCOR GTI DIAGNOSTICS, INC.!DBA GTI DIAGNOSTIC |
| CAGE Code | 49MF6 | IMMUCOR GTI DIAGNOSTICS, INC. GTI DIAGNOSTIC |
| S.A.M. Registration | 49MF6 [606034197] | IMMUCOR GTI DIAGNOSTICS, INC. GTI DIAGNOSTIC |