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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 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
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
TPHA Screen Positive Control and TPHA Screen Negative Control are run controls used in the TPHA Screen on an automated Blood Bank system. The product configuration is one (1) vial of each control.
IMMUCOR, INC.
0066828
In Commercial Distribution

  • 10888234001508 ()
0066828

  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control
TPHA Screen Diluent is a ready for use isotonic saline solution used to dilute sample plasma or serum, and control material, when testing with the TPHA Screen on an automated Blood Bank system. The product configuration is ten (10) vials.
IMMUCOR, INC.
0066827
In Commercial Distribution

  • 10888234001492 ()
0066827

  • Treponema pallidum total antibody IVD, kit, agglutination
TPHA Screen is used in the qualitative screening of blood donors for the detection of IgG and IgM antibodies to Treponema pallidum in human serum and EDTA plasma by passive hemagglutination using an automated Blood Bank system. The product configuration is ten (10) vials.
IMMUCOR, INC.
0066826
In Commercial Distribution

  • 10888234001485 ()
0066826

  • Treponema pallidum total antibody IVD, kit, agglutination
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
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