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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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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
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
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
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
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
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 single vial configuration.
IMMUCOR, INC.
0006427
In Commercial Distribution

  • 10888234000594 ()
0006427

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
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 one (1) vial configuration.
IMMUCOR, INC.
0002226
In Commercial Distribution

  • 10888234000204 ()
0002226

  • Multiple immunohaematology test IVD, control
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