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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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This polyclonal reagent is used for the detection of the K antigen (of the Kell blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004140
In Commercial Distribution

  • 10888234001836 ()
0004140

  • Anti-K (KEL001) red blood cell grouping IVD, antibody
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 LO-ION is intended as 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.
0704610
In Commercial Distribution

  • 10888234001775 ()
0704610

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
This reagent is used in slide, tube and microwell tests, for the detection of the Rh (D) antigen, of the Rhesus blood group system. The package configuration for this product code is three (3) vials of reagent.
IMMUCOR, INC.
0420503
In Commercial Distribution

  • 10888234001768 ()
0420503

  • Anti-Rh(D) red blood cell grouping IVD, antibody
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
This reagent is used in slide, tube and microplate tests, for the detection of the A and B antigens of the ABO blood group system. The package configuration for this product code is ten (10) vials of reagent.
IMMUCOR, INC.
0414210
In Commercial Distribution

  • 10888234001737 ()
0414210

  • Anti-AB red blood cell grouping IVD, antibody
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