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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 product is used in the identification of unexpected red cell blood group antibodies. This product is manufactured as 10 vials of reagent red blood cells in a set, as well as one (1) Tech Cell and also one (1) buffered preservation diluent. 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.
0003032
In Commercial Distribution

  • 10888234000396 ()
0003032

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Weak D Cells are used for quality control of weak D testing. Weak D Cells are a suspension of selected weak D red blood cells. This product is a one (1) vial configuration.
IMMUCOR, INC.
0002995
In Commercial Distribution

  • 10888234000372 ()
0002995

  • Multiple immunohaematology test IVD, control
corQC EXTEND 1, 2, and 3 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 three vial set.
IMMUCOR, INC.
0002417
In Commercial Distribution

  • 10888234000341 ()
0002417

  • Multiple immunohaematology test IVD, control
corQC Test System is used for daily quality control evaluation of routine blood bank reagents. It is a two vial set. One vial is a suspension of known red blood cells. The second vial is a known antiserum containing antibodies.
IMMUCOR, INC.
0002400
In Commercial Distribution

  • 10888234000334 ()
0002400

  • Multiple immunohaematology test IVD, control
This product is used in the detection of unexpected red blood cell blood group antibodies. This product is a two (2) vial set, with each vial containing a 2 - 4% reagent red blood cell suspension of a unique group O donor of known antigen make-up.
IMMUCOR, INC.
0002390
In Commercial Distribution

  • 10888234000327 ()
0002390

  • Antibody screening reagent red blood cell IVD, kit, agglutination
This product is used in the identification of unexpected red cell blood group antibodies. Panocell-10, Ficin-Treated is a 12-vial set of 10 vials of red blood cells, plus one vial each of Ficin Solution and Ficin Control.
IMMUCOR, INC.
0002385
In Commercial Distribution

  • 10888234000310 ()
0002385

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Panoscreen I, II, and III is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual tube method. The configuration of this product is a 3-cell screen.
IMMUCOR, INC.
0002381
In Commercial Distribution

  • 10888234000303 ()
0002381

  • Antibody screening reagent red blood cell IVD, kit, agglutination
Panoscreen I and II is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual tube method. The configuration of this product is a 2-cell screen.
IMMUCOR, INC.
0002380
In Commercial Distribution

  • 10888234000297 ()
0002380

  • Antibody screening reagent red blood cell IVD, kit, agglutination
Panoscreen I, II, and III is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual tube method. The configuration of this product is a 3-cell screen.
IMMUCOR, INC.
0002377
In Commercial Distribution

  • 10888234000280 ()
0002377

  • Antibody screening reagent red blood cell IVD, kit, agglutination
This configuration of the product contains two (2) vials, and is used for the confirmation of reverse expected ABO serum grouping antibodies.
IMMUCOR, INC.
0002345
In Commercial Distribution

  • 10888234000273 ()
0002345

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
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