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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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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
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