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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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Sepacell PLD-10ALeukocyte Reduction Y-Administration Set. Sterile Fluid Path
FENWAL, INC.
4C4502
In Commercial Distribution

  • 10811137010438 ()
  • 00811137010431 ()
4C4502

  • Blood transfusion set, non-exchange
For Collection of One Leukoreduced Red Blood Cell Product and Concurrent Plasma Product by Centrifugation. For Use With the ALYX™ System. Sterile Fluid Path.
FENWAL, INC.
4R5700
In Commercial Distribution

  • 00811137010134 ()
  • 10811137010131 ()
4R5700

  • Apheresis system tubing set
No Description
SCC SOFT COMPUTER
25.6.2.0
In Commercial Distribution

  • 00810142371827 ()


  • Blood bank information system application software
IgG-coated red blood cells for the control of antiglobulin test; 10ml
Bio-Rad Medical Diagnostics GmbH
816030100
In Commercial Distribution

  • 07611969952502 ()
816030100

  • Immunoglobulin-sensitized reagent red blood cell IVD, control
For manual Quality Control testing, Set of 5x4 mL red cells in suspension (4 +/- 1%) and 3x3 mL sera (human, polyclonal)
Bio-Rad Medical Diagnostics GmbH
814172100
In Commercial Distribution

  • 07611969952342 ()


  • Multiple immunohaematology test IVD, control
Set of 2 x 8 x5 mL pooled whole blood (15.0 ± 2.0%) for quality control testing for use with the IH-System
Bio-Rad Medical Diagnostics GmbH
814171100
In Commercial Distribution

  • 07611969952335 ()


  • Multiple immunohaematology test IVD, control
Gel card for use with the IH system; Card for antibody detection of human red blood cells; 48 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813611100
In Commercial Distribution

  • 07611969952229 ()
813611100

  • ABO/Rh multiple blood grouping IVD, kit, agglutination
Optional card for the negative control in ABO and Rh typing; 12 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813600100
In Commercial Distribution

  • 07611969952212 ()
813600100

  • Antisera matrix (non-reactive) IVD, control
Microplate for use in detection of red blood cell antibodies and antigens in indirect and direct antiglobulin tests with solid phase antiglobulin technique on TANGO instruments; 10 plates
Bio-Rad Medical Diagnostics GmbH
806521100
In Commercial Distribution

  • 07611969951499 ()
806521100

  • Solid-phase red blood cell adherence antibody/antigen IVD
Positive Control for Solidscreen II on TANGO instruments; 4ml
Bio-Rad Medical Diagnostics GmbH
806519100
In Commercial Distribution

  • 07611969951468 ()
806519100

  • Anti-Rh(D) antibody screen IVD, control
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