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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Gamma PeG is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Polyethylene Glycol (PeG) in a low ionic strength saline solution, and is the three (3) vial configuration.
IMMUCOR, INC.
0705003
In Commercial Distribution

  • 10888234001782 ()
0705003

  • Polyethylene glycol (PEG) immunohaematology reagent IVD
Gamma LO-ION is intended as an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the ten (10) vial configuration.
IMMUCOR, INC.
0704610
In Commercial Distribution

  • 10888234001775 ()
0704610

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
This reagent is used in slide, tube and microwell tests, for the detection of the Rh (D) antigen, of the Rhesus blood group system. The package configuration for this product code is three (3) vials of reagent.
IMMUCOR, INC.
0420503
In Commercial Distribution

  • 10888234001768 ()
0420503

  • Anti-Rh(D) red blood cell grouping IVD, antibody
Gamma-clone Control is intended to be used as a control for Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has ten (10) vials.
IMMUCOR, INC.
0420410
In Commercial Distribution

  • 10888234001751 ()
0420410

  • Multiple immunohaematology test IVD, control
Gamma-clone Control is intended to be used as a control for Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has three (3) vials.
IMMUCOR, INC.
0420403
In Commercial Distribution

  • 10888234001744 ()
0420403

  • Multiple immunohaematology test IVD, control
This reagent is used in slide, tube and microplate tests, for the detection of the A and B antigens of the ABO blood group system. The package configuration for this product code is ten (10) vials of reagent.
IMMUCOR, INC.
0414210
In Commercial Distribution

  • 10888234001737 ()
0414210

  • Anti-AB red blood cell grouping IVD, antibody
This reagent is used in slide, tube and microplate tests, for the detection of the B antigen of the ABO blood group system. The package configuration for this product code is ten (10) vials of reagent.
IMMUCOR, INC.
0413210
In Commercial Distribution

  • 10888234001720 ()
0413210

  • Anti-B red blood cell grouping IVD, antibody
This reagent is used in slide, tube and microplate tests, for the detection of the B antigen of the ABO blood group system. The package configuration for this product code is three (3) vials of reagent.
IMMUCOR, INC.
0413203
In Commercial Distribution

  • 10888234001713 ()
0413203

  • Anti-B red blood cell grouping IVD, antibody
This reagent is used in slide, tube and microplate tests, for the detection of the A antigen of the ABO blood group system. The package configuration for this product code is ten (10) vials of reagent.
IMMUCOR, INC.
0410210
In Commercial Distribution

  • 10888234001706 ()
0410210

  • Anti-A red blood cell grouping IVD, antibody
This reagent is used in slide, tube and microplate tests, for the detection of the A antigen of the ABO blood group system. The package configuration for this product code is three (3) vials of reagent.
IMMUCOR, INC.
0410203
In Commercial Distribution

  • 10888234001690 ()
0410203

  • Anti-A red blood cell grouping IVD, antibody
This product is used in direct or indirect antiglobulin tests where the detection of IgG or C3 (as C3b or C3d) is required. This product contains a blend of murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG, anti-C3d and anti-C3b. The package configuration for this product code is ten (10) vials of reagent. The color of the liquid reagent is green.
IMMUCOR, INC.
0409710
In Commercial Distribution

  • 10888234001683 ()
0409710

  • Monospecific anti-complement component C3d (anti-C3d) IVD, antibody
This product is used in direct or indirect antiglobulin tests where the detection of IgG or C3 (as C3b or C3d) is required. This product contains a blend of murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG, anti-C3d and anti-C3b. The package configuration for this product code is three (3) vials of reagent. The color of the liquid reagent is green.
IMMUCOR, INC.
0409703
In Commercial Distribution

  • 10888234001676 ()
0409703

  • Monospecific anti-complement component C3d (anti-C3d) IVD, antibody
This product is used in direct or indirect antiglobulin tests where the detection of IgG is required. This product contains a murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG. The package configuration for this product code is ten (10) vials of reagent. The color of the liquid reagent is green.
IMMUCOR, INC.
0409210
In Commercial Distribution

  • 10888234001669 ()
0409210

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
This product is used in direct or indirect antiglobulin tests where the detection of IgG is required. This product contains a murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG. The package configuration for this product code is three (3) vials of reagent. The color of the liquid reagent is green.
IMMUCOR, INC.
0409203
In Commercial Distribution

  • 10888234001652 ()
0409203

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
This product is used in direct or indirect antiglobulin tests where the detection of IgG is required. This product contains a murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG. The package configuration for this product code is ten (10) vials of reagent. The color of the liquid reagent is clear.
IMMUCOR, INC.
0401510
In Commercial Distribution

  • 10888234001645 ()
0401510

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
This product is used in direct or indirect antiglobulin tests where the detection of IgG or C3 (as C3b or C3d) is required. This product contains a blend of murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG, anti-C3d and anti-C3b. The package configuration for this product code is ten (10) vials of reagent. The color of the liquid reagent is clear.
IMMUCOR, INC.
0401010
In Commercial Distribution

  • 10888234001638 ()
0401010

  • Monospecific anti-complement component C3d (anti-C3d) IVD, antibody
Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture-R Solid Phase Assays, including Capture-R Select, Capture-R Ready-Screen and Capture-R Ready-ID. Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells and sodium azide added as a preservative. Capture-R Negative Control Serum contains no antibodies to red blood cells; sodium azide is added as a preservative.
IMMUCOR, INC.
0066902
In Commercial Distribution

  • 10888234001546 ()
0066902

  • Total immunoglobulin G (IgG total) IVD, control
TPHA Screen Positive Control and TPHA Screen Negative Control are run controls used in the TPHA Screen on an automated Blood Bank system. The product configuration is one (1) vial of each control.
IMMUCOR, INC.
0066828
In Commercial Distribution

  • 10888234001508 ()
0066828

  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control
TPHA Screen Diluent is a ready for use isotonic saline solution used to dilute sample plasma or serum, and control material, when testing with the TPHA Screen on an automated Blood Bank system. The product configuration is ten (10) vials.
IMMUCOR, INC.
0066827
In Commercial Distribution

  • 10888234001492 ()
0066827

  • Treponema pallidum total antibody IVD, kit, agglutination
TPHA Screen is used in the qualitative screening of blood donors for the detection of IgG and IgM antibodies to Treponema pallidum in human serum and EDTA plasma by passive hemagglutination using an automated Blood Bank system. The product configuration is ten (10) vials.
IMMUCOR, INC.
0066826
In Commercial Distribution

  • 10888234001485 ()
0066826

  • Treponema pallidum total antibody IVD, kit, agglutination
This reagent is used for the detection of the K antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0066451
In Commercial Distribution

  • 10888234001393 ()
0066451

  • Anti-K (KEL001) red blood cell grouping IVD, antibody
This reagent is used for the detection of the c antigen (Rhesus blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0066425
In Commercial Distribution

  • 10888234001386 ()
0066425

  • Anti-C [RH004] red blood cell grouping IVD, antibody
This reagent is used for the detection of the e antigen (Rhesus blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0066424
In Commercial Distribution

  • 10888234001379 ()
0066424

  • Anti-E [RH005] red blood cell grouping IVD, antibody
This reagent is intended for the detection of the E antigen on red blood cells. This E antigen is part of the Rhesus blood group system.
IMMUCOR, INC.
0066422
In Commercial Distribution

  • 10888234001362 ()
0066422

  • Anti-E [RH003] red blood cell grouping IVD, antibody
This reagent is used for the detection of the C antigen (Rhesus blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0066421
In Commercial Distribution

  • 10888234001355 ()
0066421

  • Anti-C [RH002] red blood cell grouping IVD, antibody
This reagent is intended for use in slide, tube and microplate tests, for the detection of the Rh (D) antigen.
IMMUCOR, INC.
0066420
In Commercial Distribution

  • 10888234001348 ()
0066420

  • Anti-Rh(D) red blood cell grouping IVD, antibody
corQC EXTEND Complete is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a five vial set.
IMMUCOR, INC.
0066297
In Commercial Distribution

  • 10888234001331 ()
0066297

  • Multiple immunohaematology test IVD, control
corQC EXTEND Standard is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a single vial product.
IMMUCOR, INC.
0066296
In Commercial Distribution

  • 10888234001324 ()
0066296

  • Multiple immunohaematology test IVD, control
Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the five (5) microplate product.
IMMUCOR, INC.
0066251
In Commercial Distribution

  • 10888234001300 ()
0066251

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
The Capture-P Control set is composed of both negative and weak positive control material to control both the Capture-P and Capture-P Ready-Screen tests.
IMMUCOR, INC.
0066248
In Commercial Distribution

  • 10888234001294 ()
0066248

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the single microplate product.
IMMUCOR, INC.
0066246
In Commercial Distribution

  • 10888234001270 ()
0066246

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
Capture-P Indicator Red Cells are part of both the Capture-P and Capture-P Ready-Screen tests, and they are used to visualize the final reaction.
IMMUCOR, INC.
0066240
In Commercial Distribution

  • 10888234001256 ()
0066240

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
The Capture-CMV Control set is composed of both negative and weak positive control material to control the Capture-CMV test.
IMMUCOR, INC.
0066239
In Commercial Distribution

  • 10888234001249 ()
0066239

  • Cytomegalovirus (CMV) antigen IVD, reagent
Capture-CMV Indicator Red Cells are part of the Capture-CMV test, and they are used to visualize the final reaction.
IMMUCOR, INC.
0066238
In Commercial Distribution

  • 10888234001232 ()
0066238

  • Cytomegalovirus (CMV) antigen IVD, reagent
Capture-R Control set (Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum) are run controls to be used in Capture-R solid phase assays. The Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells. The Capture-R Negative Control Serum does not contain antibodies to red blood cells. This product configuration has one (1) vial of each control, at a volume of 11.5 mL each.
IMMUCOR, INC.
0066236
In Commercial Distribution

  • 10888234001225 ()
0066236

  • Solid-phase red blood cell adherence antibody/antigen IVD
Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies. This product is the 57 mL bottle version with six bottles packaged.
IMMUCOR, INC.
0066231
In Commercial Distribution

  • 10888234001218 ()
0066231

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
DAT Positive Control Cell is designed to be used only with the Immucor automated instruments. DAT Positive Control Cells are IgG-coated red blood cells used as a control to confirm the validity of the DAT assay and other assays utilizing the direct antiglobulin test on Immucor automated instruments. This product is the four (4) vial configuration.
IMMUCOR, INC.
0066125
In Commercial Distribution

  • 10888234001119 ()
0066125

  • Multiple immunohaematology test IVD, control
DAT Positive Control Cell is designed to be used only with the Immucor automated instruments. DAT Positive Control Cells are IgG-coated red blood cells used as a control to confirm the validity of the DAT assay and other assays utilizing the direct antiglobulin test on Immucor automated instruments. This product is the one (1) vial configuration.
IMMUCOR, INC.
0066122
In Commercial Distribution

  • 10888234001102 ()
0066122

  • Multiple immunohaematology test IVD, control
WB corQC is incorporated as a set of run controls with blood sample testing for the daily quality control of blood bank reagents on automated instruments. A set of WB corQC is composed of four tubes of varying antigenic and antibody makeup. Each packaging of the WB corQC product contains a pair of each of the four tubes.
IMMUCOR, INC.
0066090
In Commercial Distribution

  • 10888234001096 ()
0066090

  • Multiple immunohaematology test IVD, control
Monoclonal Control is intended to be used as a control for Immucor low protein Blood Grouping Reagents and Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has ten (10) vials.
IMMUCOR, INC.
0066089
In Commercial Distribution

  • 10888234001089 ()
0066089

  • Multiple immunohaematology test IVD, control
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