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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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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
Negative Control for Solidscreen II on TANGO instruments; 4 ml
Bio-Rad Medical Diagnostics GmbH
806509100
In Commercial Distribution

  • 07611969951352 ()
806509100

  • Anti-Rh(D) antibody screen IVD, control
Reagent for the negative control in ABO and RH typing with Seraclone ABO and Rh reagent for tube test; 10 ml
Bio-Rad Medical Diagnostics GmbH
805171100
In Commercial Distribution

  • 07611969950874 ()
805171100

  • Antisera matrix (non-reactive) IVD, control
No Description
Bio-Rad Medical Diagnostics GmbH
009303
In Commercial Distribution

  • 07611969226344 ()


  • Test tube heater
IH-Centrifuge L for centrifugation of IH-System gel cards and/or test tubes.
Bio-Rad Medical Diagnostics GmbH
009301
In Commercial Distribution

  • 07611969226320 ()


  • General-purpose centrifuge IVD
No Description
SCC SOFT COMPUTER
25.6.2.0
In Commercial Distribution

  • 00810142371827 ()


  • Blood bank information system application software
WellSky Transfusion 2024 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2024 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT 128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional) WellSky Transfusion 2024 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2024
In Commercial Distribution

  • B105TRANSFUSION20240 ()


  • Blood bank information system application software
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