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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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Coombscell-E - 07611969952502

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

IH-Internal QC - 07611969952342

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

IH-Basic QC - 07611969952335

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

IH-Card Neutral - 07611969952229

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

IH-Card Control - 07611969952212

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

Solidscreen II Strip - 07611969951499

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

Solidscreen II Negative Control - 07611969951352

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

Seraclone Control AB0+Rh - 07611969950874

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

IH-Incubator L - 07611969226344

No Description
Bio-Rad Medical Diagnostics GmbH
009303
In Commercial Distribution

  • 07611969226344 ()


  • Test tube heater

IH-Centrifuge L - 07611969226320

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
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