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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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 one (1) vial.
IMMUCOR, INC.
0066087
In Commercial Distribution

  • 10888234002178 ()
0066087

  • Multiple immunohaematology test IVD, control
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 single 57 mL bottle version.
IMMUCOR, INC.
0006418
In Commercial Distribution

  • 10888234002147 ()
0006418

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Gamma N-HANCE is used 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.
0705410
In Commercial Distribution

  • 10888234001812 ()
0705410

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Gamma N-HANCE is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the three (3) vial configuration.
IMMUCOR, INC.
0705403
In Commercial Distribution

  • 10888234001805 ()
0705403

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
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 ten (10) vial configuration.
IMMUCOR, INC.
0705010
In Commercial Distribution

  • 10888234001799 ()
0705010

  • Polyethylene glycol (PEG) immunohaematology reagent IVD
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-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
CMT Plates are intended to be used in hemagglutination assays on Immucor automated instruments. CMT Plates are composed of micro-wells coated to block the nonspecific adsorption of red blood cells or serum proteins to the plastic wells. CMT Plates are supplied in a plate format. Each plate has twelve strips on a support frame and each strip has eight micro-wells. Strips can be used individually or in multiples. This product configuration is forty (40) microplates.
IMMUCOR, INC.
0089000
In Commercial Distribution

  • 10888234001591 ()
0089000

  • Immunohaematology/blood bank analyser IVD
The Galileo Echo is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo Echo automates test processing, result interpretation, and data management functions. The Galileo Echo is designed to automate standard immunohematology assays using a microstrip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping.
IMMUCOR, INC.
0087000
In Commercial Distribution

  • 10888234001584 ()
0087000

  • Immunohaematology/blood bank analyser IVD
Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capture-P and Capture-P Ready-Screen Solid Phase assays.
IMMUCOR, INC.
0066905
In Commercial Distribution

  • 10888234001577 ()
0066905

  • 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. Capture-P Solid Phase System is designed to detect the unexpected antiplatelet antibodies (antibody screening test) in a patient or donor population.
IMMUCOR, INC.
0066904
In Commercial Distribution

  • 10888234001560 ()
0066904

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
The Capture-R Select Solid Phase System provides modified microwells for the immobilization of human erythrocytes for use in solid phase assays for the detection of IgG red blood cell antibodies to corresponding red blood cell antigens (e.g., antibody screening, selected red blood cell panels, crossmatching, or antigen phenotyping).
IMMUCOR, INC.
0066903
In Commercial Distribution

  • 10888234001553 ()
0066903

  • Solid-phase red blood cell adherence antibody/antigen IVD
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 Ready-Screen solid phase system is used to detect IgG HLA and platelet specific antibodies to platelets. This is a single microplate product.
IMMUCOR, INC.
0066247
In Commercial Distribution

  • 10888234001287 ()
0066247

  • 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
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
Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blood samples for testing on Immucor automated instruments. This product configuration is six (6) vials of 57 mL volume.
IMMUCOR, INC.
0066053
In Commercial Distribution

  • 10888234001072 ()
0066053

  • Cell preservation/storage/dilution solution IVD
Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blood samples for testing on Immucor automated instruments. This product configuration is ten (10) vials of 11.5 mL volume.
IMMUCOR, INC.
0066052
In Commercial Distribution

  • 10888234001065 ()
0066052

  • Cell preservation/storage/dilution solution IVD
W.A.R.M. (Warm Autoantibody Removal Medium) is used for the removal of warm-reactive autoantibody from red blood cells to facilitate resolution of serological complexities. W.A.R.M. is a specially formulated preparation of dithiothreitol and cysteine-activated papain in a phosphate buffer. It has been filtered and lyophilized. This product must be reconstituted with deionized water and mixed thoroughly prior to use. The product configuration is ten (10) vials.
IMMUCOR, INC.
0057319
In Commercial Distribution

  • 10888234001010 ()
0057319

  • Papain immunohaematology reagent IVD
Anti-A1 Lectin (Dolichos biflorus) Blood Grouping Lectin is used to differentiate A1 red blood cells from those of other A subgroups in saline slide or tube tests. This is a lectin product. This product is in a single vial configuration.
IMMUCOR, INC.
0012280
In Commercial Distribution

  • 10888234000952 ()
0012280

  • Anti-A1 red blood cell grouping IVD, lectin
The FMH RapidScreen kit is intended for use in the detection of D-positive red blood cells in D-negative mothers.
IMMUCOR, INC.
0007893
In Commercial Distribution

  • 10888234000907 ()
0007893

  • Foeto-maternal haemorrhage/Kleihauer test IVD, reagent
Gamma EGA Kit is intended for use in dissociation of IgG from red blood cells so that the treated red blood cells can be further antigen typed or used for serological testing.
IMMUCOR, INC.
0007865
In Commercial Distribution

  • 10888234000877 ()
0007865

  • Red cell antibody eluting IVD, kit
Gamma ELU-KIT II is intended for use in the rapid acid elution of antibodies from intact red blood cells.
IMMUCOR, INC.
0007861
In Commercial Distribution

  • 10888234000860 ()
0007861

  • Red cell antibody eluting IVD, kit
GammaZyme-B is used in one-stage enzyme test systems for blood group antibody detection. GammaZyme-B is a stabilized solution of bromelin, and this product is in a single vial configuration.
IMMUCOR, INC.
0007058
In Commercial Distribution

  • 10888234000716 ()
0007058

  • Bromelin immunohaematology reagent IVD
GammaZyme-F is used in two-stage (pretreatment of red blood cells) enzyme test systems for blood group antibody detection. GammaZyme-F is a stabilized solution of ficin, and this product is in a single vial configuration.
IMMUCOR, INC.
0007056
In Commercial Distribution

  • 10888234000709 ()
0007056

  • Ficin immunohaematology reagent IVD
Capture-R Select solid phase system provides modified micro-wells for the immobilization of human erythrocytes for use in solid phase assays for the detection of IgG red blood cell antibodies to corresponding red blood cell antigens (e.g., antibody screening, selected red blood cell panels, crossmatching, or antigen phenotyping). This product is the five (5) plate configuration.
IMMUCOR, INC.
0006446
In Commercial Distribution

  • 10888234000655 ()
0006446

  • Microplate IVD
This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the ten (10) vial configuration.
IMMUCOR, INC.
0006428
In Commercial Distribution

  • 10888234000600 ()
0006428

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the single vial configuration.
IMMUCOR, INC.
0006427
In Commercial Distribution

  • 10888234000594 ()
0006427

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
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 11.5 mL vial version with ten vials packaged.
IMMUCOR, INC.
0006420
In Commercial Distribution

  • 10888234000587 ()
0006420

  • Low ionic-strength salt solution (LISS) immunohaematology reagent 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 11.5 mL vial version with one vial packaged.
IMMUCOR, INC.
0006419
In Commercial Distribution

  • 10888234000570 ()
0006419

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Platelet Wash and Storage Solution (PWSS) is used to wash, suspend and store platelets. The solution is provided in a 1 liter bag.
IMMUCOR, INC.
0005035
In Commercial Distribution

  • 10888234000488 ()
0005035

  • Platelet storage solution
corQC EXTEND 1, 2, and 3 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 three vial set.
IMMUCOR, INC.
0002417
In Commercial Distribution

  • 10888234000341 ()
0002417

  • Multiple immunohaematology test IVD, control
corQC Test System is used for daily quality control evaluation of routine blood bank reagents. It is a two vial set. One vial is a suspension of known red blood cells. The second vial is a known antiserum containing antibodies.
IMMUCOR, INC.
0002400
In Commercial Distribution

  • 10888234000334 ()
0002400

  • Multiple immunohaematology test IVD, control
Bovine Albumin Solution 22% is intended for use as a high protein potentiator in crossmatch, antibody identification and antibody titration procedures. This product is prepared from bovine serum albumin and is the ten (10) vial configuration.
IMMUCOR, INC.
0002327
In Commercial Distribution

  • 10888234000235 ()
0002327

  • Bovine serum albumin (BSA) immunohaematology reagent IVD
Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration.
IMMUCOR, INC.
0002227
In Commercial Distribution

  • 10888234000211 ()
0002227

  • Multiple immunohaematology test IVD, control
Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration.
IMMUCOR, INC.
0002226
In Commercial Distribution

  • 10888234000204 ()
0002226

  • Multiple immunohaematology test IVD, control
Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration.
IMMUCOR, INC.
0002225
In Commercial Distribution

  • 10888234000198 ()
0002225

  • Multiple immunohaematology test IVD, control
Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration.
IMMUCOR, INC.
0002224
In Commercial Distribution

  • 10888234000181 ()
0002224

  • Multiple immunohaematology test IVD, control
ImmuAdd is intended for use as a potentiator in antibody detection, antibody identification and compatibility procedures. This product is prepared from glycine and salt-poor bovine albumin, and is the ten (10) vial configuration.
IMMUCOR, INC.
0002008
In Commercial Distribution

  • 10888234000167 ()
0002008

  • Bovine serum albumin (BSA) immunohaematology reagent IVD
ADAM-rWBC2 is a device to count white blood cell. It is used with ADAM-rWBC Kit.
NanoEnTek, Inc.
ADAM-rWBC2
In Commercial Distribution

  • 08809317540498 ()
ADAM-rWBC2

  • White blood cell count IVD, kit, cell count
ADAM-rWBC is a device to count white blood cell. It is used with ADAM-rWBC kit.
NanoEnTek, Inc.
ADAM-rWBC
In Commercial Distribution

  • 08809317540252 ()
ADAM-rWBC

  • White blood cell count IVD, kit, cell count
Device, Blood Mixing And Weighing
Fresenius Kabi AG
9029651
In Commercial Distribution

  • 04086000860758 ()
9029651

  • Blood donation rocker
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