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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 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
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