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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-D Series 5 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen.
IMMUCOR, INC.
0006414
In Commercial Distribution

  • 10888234000563 ()
0006414

  • Anti-Rh(D) red blood cell grouping IVD, antibody
Anti-D Series 4 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen.
IMMUCOR, INC.
0006412
In Commercial Distribution

  • 10888234000556 ()
0006412

  • Anti-Rh(D) red blood cell grouping IVD, antibody
This product is intended for use in slide, tube, and microplate tests, for the detection of both the A and B antigens.
IMMUCOR, INC.
0006408
In Commercial Distribution

  • 10888234000549 ()
0006408

  • Anti-AB red blood cell grouping IVD, antibody
Anti-B (Murine Monoclonal) Series 3 is intended for use in slide, tube, microplate and automated tests, for the detection of the B antigen.
IMMUCOR, INC.
0006406
In Commercial Distribution

  • 10888234000532 ()
0006406

  • Anti-B red blood cell grouping IVD, antibody
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
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