Immucor GTI Diagnostics, Inc

FDA Filings

This page includes the latest FDA filings for Immucor GTI Diagnostics, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Immucor GTI Diagnostics, Inc.
Qualitative Test For HLA, Non-diagnostic2020-01-21
Immucor GTI Diagnostics, Inc.
Qualitative Test For HLA, Non-diagnostic2018-06-14
Immucor GTI Diagnostics, Inc.
Qualitative Test For HLA, Non-diagnostic2016-04-21
Immucor GTI Diagnostics, Inc.
Platelet Antibody Test2015-04-27
Immucor GTI Diagnostics, Inc.
Qualitative Test For HLA, Non-diagnostic2013-09-23

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
LIFECODES® QuikScreen®
IMMUCOR GTI DIAGNOSTICS, INC.2019-12-16
LIFECODES® B-Screen®
IMMUCOR GTI DIAGNOSTICS, INC.2019-12-16
Dilution Solution
IMMUCOR GTI DIAGNOSTICS, INC.2019-01-10
Negative Control Serum
IMMUCOR GTI DIAGNOSTICS, INC.2019-01-10
Positive Control Serum
IMMUCOR GTI DIAGNOSTICS, INC.2019-01-10
Negative Control Serum
IMMUCOR GTI DIAGNOSTICS, INC.2019-01-10
Positive Control Serum
IMMUCOR GTI DIAGNOSTICS, INC.2019-01-10
LIFECODES Wash Buffer
IMMUCOR GTI DIAGNOSTICS, INC.2019-01-10
Negative Control Serum
IMMUCOR GTI DIAGNOSTICS, INC.2019-01-10
Positive Control Serum
IMMUCOR GTI DIAGNOSTICS, INC.2019-01-10
ThromboType®
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-15
PNPP Substrate
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Positive Serum Control
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Positive Serum Control
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Positive Serum Control
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Positive Serum Control
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Positive Serum Control
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Cell Resuspension and Preservative Solution
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Anti-Human IgG/A/M Conjugate
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Negative Serum Control
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Negative Serum Control
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Negative Serum Control
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Negative Serum Control
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Negative Serum Control
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Eluting Solution
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Buffering Solution
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Anti-Human IgG Conjugate
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Anti-Human IgG Conjugate
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Specimen Diluent
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Substrate Buffer
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Stopping Solution
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Positive Control
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Negative Control
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Kit Control
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01
Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.2018-08-01

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