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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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IOTest CD3-PC7 (IVD not sold in the US or Canada) - 15099590391553

IOTest CD3-PC7
Beckman Coulter, Inc.
737657
In Commercial Distribution

  • 15099590391553 ()
737657

  • Multiple CD cell marker IVD, antibody

CS CD8-ECD (IVD not sold in the US or Canada) - 15099590391546

CYTO-STAT/COULTER CLONE CD8-ECD
Beckman Coulter, Inc.
737659
In Commercial Distribution

  • 15099590391546 ()
737659

  • Multiple CD cell marker IVD, antibody

IOTest CD4-PC7 (IVD not sold in the US or Canada) - 15099590391539

IOTest CD4-PC7
Beckman Coulter, Inc.
737660
In Commercial Distribution

  • 15099590391539 ()
737660

  • Multiple CD cell marker IVD, antibody

IOTest CD8-PC7 (IVD not sold in the US or Canada) - 15099590391522

IOTest CD8-PC7
Beckman Coulter, Inc.
737661
In Commercial Distribution

  • 15099590391522 ()
737661

  • Multiple CD cell marker IVD, antibody

IOTest MsIgG1-PC7 (IVD not sold in the US or Canada) - 15099590391515

IOTest MsIgG1-PC7
Beckman Coulter, Inc.
737662
In Commercial Distribution

  • 15099590391515 ()
737662

  • Multiple CD cell marker IVD, control

QuickCOMP 2 Kit - 15099590232948

QuickComp 2 Kit
Beckman Coulter, Inc.
177018
In Commercial Distribution

  • 15099590232948 ()
177018

  • Multiple CD cell marker IVD, antibody

QuickCOMP 4 Kit - 15099590232931

QuickComp 4 Kit
Beckman Coulter, Inc.
177017
In Commercial Distribution

  • 15099590232931 ()
177017

  • Multiple CD cell marker IVD, antibody

AQUIOS IMMUNO-TROL Low Cells - 15099590225865

AQUIOS Immuno-Trol Low Cells
BECKMAN COULTER IRELAND INC.
B25700
In Commercial Distribution

  • 15099590225865 ()
B25700

  • Multiple CD cell marker IVD, control

AQUIOS IMMUNO-TROL Cells - 15099590225759

AQUIOS Immuno-Trol Cells
BECKMAN COULTER IRELAND INC.
B23535
In Commercial Distribution

  • 15099590225759 ()
B23535

  • Multiple CD cell marker IVD, control

AQUIOS Tetra-2+ Panel - 15099590225735

AQUIOS Tetra-2+ Panel CD45-FITC/(CD56 + CD16)-RD1/CD19-ECD/CD3-PC5
BECKMAN COULTER IRELAND INC.
B23534
In Commercial Distribution

  • 15099590225735 ()
B23534

  • Multiple CD cell marker IVD, antibody
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