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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 Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the single vial configuration.
IMMUCOR, INC.
0006427
In Commercial Distribution

  • 10888234000594 ()
0006427

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies. This product is the 11.5 mL vial version with ten vials packaged.
IMMUCOR, INC.
0006420
In Commercial Distribution

  • 10888234000587 ()
0006420

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies. This product is the 11.5 mL vial version with one vial packaged.
IMMUCOR, INC.
0006419
In Commercial Distribution

  • 10888234000570 ()
0006419

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
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
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