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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 reagent is intended for the detection of the M antigen on red blood cells by tube test.
IMMUCOR, INC.
0004802
In Commercial Distribution

  • 10888234000464 ()
0004802

  • Anti-M red blood cell grouping IVD, antibody
This reagent is intended for the detection of the P1 antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004501
In Commercial Distribution

  • 10888234000457 ()
0004501

  • Anti-P1 red blood cell grouping IVD, antibody
This reagent is used for the detection of the K antigen on red blood cells by tube test.
IMMUCOR, INC.
0004210
In Commercial Distribution

  • 10888234000440 ()
0004210

  • Anti-K (KEL001) red blood cell grouping IVD, antibody
This reagent is used in direct antiglobulin tests where the detection of C3 (as C3b or C3d) is required. This product configuration is a single vial.
IMMUCOR, INC.
0004068
In Commercial Distribution

  • 10888234000402 ()
0004068

  • Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody
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
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