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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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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-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
The Galileo Echo is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo Echo automates test processing, result interpretation, and data management functions. The Galileo Echo is designed to automate standard immunohematology assays using a microstrip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping.
IMMUCOR, INC.
0087000
In Commercial Distribution

  • 10888234001584 ()
0087000

  • Immunohaematology/blood bank analyser IVD
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
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
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