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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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CC T8-RD1 - 15099590537012

COULTER CLONE T8-RD1
Beckman Coulter, Inc.
6603274
In Commercial Distribution

  • 15099590537012 ()
6603274

  • Multiple CD cell marker IVD, antibody

COULTER CLONE I3-FITC - 15099590536992

COULTER CLONE I3-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6603424
In Commercial Distribution

  • 15099590536992 ()
6603424

  • 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 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

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

AQUIOS Tetra-1 Panel - 15099590225704

AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5
BECKMAN COULTER IRELAND INC.
B23533
In Commercial Distribution

  • 15099590225704 ()
B23533

  • Multiple CD cell marker IVD, antibody

COULTER CLONE MY4 - 15099590207076

COULTER CLONE MY4 (Analyte Specific Reagent)
Beckman Coulter, Inc.
A83482
In Commercial Distribution

  • 15099590207076 ()
A83482

  • Multiple CD cell marker IVD, antibody

COULTER CLONE T8 - 15099590207052

COULTER CLONE T8 (Analyte Specific Reagent)
Beckman Coulter, Inc.
A83480
In Commercial Distribution

  • 15099590207052 ()
A83480

  • Multiple CD cell marker IVD, antibody
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