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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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Monoclonal Control - 10888234002178

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 - 10888234002147

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

CMT Plates - 10888234001591

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

Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum - 10888234001577

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 - 10888234001560

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

Capture-R Select - 10888234001553

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 - 10888234001331

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

Capture-P Control set - 10888234001294

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

DAT Positive Control Cell - 10888234001119

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

GammaZyme-F - 10888234000709

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
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