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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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Anti-B (Murine Monoclonal) Series 3 is intended for use in slide, tube, microplate and automated tests, for the detection of the B antigen.
IMMUCOR, INC.
0006407
In Commercial Distribution

  • 10888234001997 ()
0006407

  • Anti-B red blood cell grouping IVD, antibody
This reagent is used in slide, tube, microplate and automated tests, for the detection of the A antigen of the ABO blood group system. The package configuration for this product code is one (1) vial of reagent.
IMMUCOR, INC.
0006401
In Commercial Distribution

  • 10888234001980 ()
0006401

  • Anti-A red blood cell grouping IVD, antibody
This reagent is intended for the detection of the N antigen on red blood cells by tube test.
IMMUCOR, INC.
0004807
In Commercial Distribution

  • 10888234001904 ()
0004807

  • Anti-N red blood cell grouping IVD, antibody
This reagent is used for the detection of the Leb antigen (of the Lewis system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004864
In Commercial Distribution

  • 10888234001898 ()
0004864

  • Anti-Le^b red blood cell grouping IVD, antibody
This reagent is used for the detection of the Lea antigen (of the Lewis system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004861
In Commercial Distribution

  • 10888234001881 ()
0004861

  • Anti-Le^a red blood cell grouping IVD, antibody
This product is used in the identification of unexpected red cell blood group antibodies. This product is manufactured as twenty (20) vials of reagent in a set. Reagent red blood cell vials each contain a 2-4% suspension of group O red blood cells prepared in a buffered preservative solution.
IMMUCOR, INC.
0005020
In Commercial Distribution

  • 10888234001843 ()
0005020

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
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
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