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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-A (Murine Monoclonal) Series 1 is intended for use in slide, tube, microplate and automated tests, for the detection of the A antigen.
IMMUCOR, INC.
0006400
In Commercial Distribution

  • 10888234000525 ()
0006400

  • Anti-A red blood cell grouping IVD, antibody
Red Blood Cell (RBC) Storage Solution is a general purpose reagent intended for use in suspending and preserving red blood cells that can be subsequently used for in vitro immunohematology testing. Red Blood Cell (RBC) Storage Solution is a buffered preservation solution containing adenosine and adenine to retard hemolysis and/or loss of antigenicity. The product is a one (1) liter bag configuration.
IMMUCOR, INC.
0005036
In Commercial Distribution

  • 10888234000495 ()
0005036

  • Cell preservation/storage/dilution solution IVD
Platelet Wash and Storage Solution (PWSS) is used to wash, suspend and store platelets. The solution is provided in a 1 liter bag.
IMMUCOR, INC.
0005035
In Commercial Distribution

  • 10888234000488 ()
0005035

  • Platelet storage solution
Di(a+) Cell is used in the detection of unexpected red blood cell blood group antibodies. Di(a+) Cell is a single vial of group O, Di(a+) red blood cells.
IMMUCOR, INC.
0005021
In Commercial Distribution

  • 10888234000471 ()
0005021

  • Di^a positive reagent red blood cell IVD, antigen
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
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
This configuration of the product contains one (1) vial, namely known A2 red blood cells, and is used for the confirmation of reverse expected ABO serum grouping antibodies.
IMMUCOR, INC.
0002342
In Commercial Distribution

  • 10888234000266 ()
0002342

  • Group A2 Rh (D) positive reagent red blood cell IVD, antigen
This configuration of the product contains four (4) vials, and is used for the confirmation of reverse expected ABO serum grouping antibodies.
IMMUCOR, INC.
0002338
In Commercial Distribution

  • 10888234000259 ()
0002338

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
This product is used in the identification of unexpected red cell blood group antibodies. This product is manufactured as 16 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.
0002332
In Commercial Distribution

  • 10888234000242 ()
0002332

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Bovine Albumin Solution 22% is intended for use as a high protein potentiator in crossmatch, antibody identification and antibody titration procedures. This product is prepared from bovine serum albumin and is the ten (10) vial configuration.
IMMUCOR, INC.
0002327
In Commercial Distribution

  • 10888234000235 ()
0002327

  • Bovine serum albumin (BSA) immunohaematology reagent IVD
Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration.
IMMUCOR, INC.
0002227
In Commercial Distribution

  • 10888234000211 ()
0002227

  • Multiple immunohaematology test IVD, control
Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration.
IMMUCOR, INC.
0002226
In Commercial Distribution

  • 10888234000204 ()
0002226

  • Multiple immunohaematology test IVD, control
Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration.
IMMUCOR, INC.
0002225
In Commercial Distribution

  • 10888234000198 ()
0002225

  • Multiple immunohaematology test IVD, control
Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration.
IMMUCOR, INC.
0002224
In Commercial Distribution

  • 10888234000181 ()
0002224

  • Multiple immunohaematology test IVD, control
Hemantigen (Pooled Cells) is used in the detection of unexpected red blood cell blood group antibodies for blood donors. Hemantigen is a single vial pool of equal amounts of reagent red blood cells from two (2) group O donors.
IMMUCOR, INC.
0002223
In Commercial Distribution

  • 10888234000174 ()
0002223

  • Pooled antibody screening reagent red blood cell IVD, antigen
ImmuAdd is intended for use as a potentiator in antibody detection, antibody identification and compatibility procedures. This product is prepared from glycine and salt-poor bovine albumin, and is the ten (10) vial configuration.
IMMUCOR, INC.
0002008
In Commercial Distribution

  • 10888234000167 ()
0002008

  • Bovine serum albumin (BSA) immunohaematology reagent IVD
No Description
SEPTODONT, INC
01C2080
In Commercial Distribution

  • 00303620000857 ()

  • Weight: 4.5 Gram


  • Dental etching solution
  • Dental composite resin
  • Dentine adhesive
No Description
SEPTODONT, INC
01C2030
In Commercial Distribution

  • 00303620000611 ()

  • Total Volume: 5 Milliliter
01C2030

  • Dentine adhesive
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