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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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CS/CC T11-FITC (CD2-FITC) - 15099590540692

CYTO-STAT/COULTER CLONE T11-FITC
Beckman Coulter, Inc.
6603863
In Commercial Distribution

  • 15099590540692 ()
6603863

  • Multiple CD cell marker IVD, antibody

CS/CC MsIgG1-FITC - 15099590540685

CYTO-STAT/COULTER CLONE MsIgG1-FITC
Beckman Coulter, Inc.
6603864
In Commercial Distribution

  • 15099590540685 ()
6603864

  • Multiple CD cell marker IVD, control

CS triCHROME CD8-FITC/CD4-RD1/CD3-PC5 - 15099590540531

CYTO-STAT triCHROME CD8-FITC/CD4-RD1/CD3-PC5
Beckman Coulter, Inc.
6607053
In Commercial Distribution

  • 15099590540531 ()
6607053

  • Multiple CD cell marker IVD, antibody

CS triCHROME CD45-FITC/CD56-RD1/CD3-PC5 - 15099590540456

CYTO-STAT triCHROME CD45-FITC/CD56-RD1/CD3-PC5
Beckman Coulter, Inc.
6607071
In Commercial Distribution

  • 15099590540456 ()
6607071

  • Multiple CD cell marker IVD, antibody

IMMUNO-TROL Cells - 15099590540449

IMMUNO-TROL Cells
Beckman Coulter, Inc.
6607077
In Commercial Distribution

  • 15099590540449 ()
6607077

  • Multiple CD cell marker IVD, control

CS tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 - 15099590540425

CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5
Beckman Coulter, Inc.
6607013
In Commercial Distribution

  • 15099590540425 ()
6607013

  • Multiple CD cell marker IVD, antibody

CS triCHROME CD45-FITC/CD4-RD1/CD3-PC5 - 15099590540418

CYTO-STAT triCHROME CD45-FITC/CD4-RD1/CD3-PC5
Beckman Coulter, Inc.
6607015
In Commercial Distribution

  • 15099590540418 ()
6607015

  • Multiple CD cell marker IVD, antibody

CS/CC CD3(IgG1)-FITC/B4-RD1 - 15099590538170

CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC/B4-RD1
Beckman Coulter, Inc.
6605015
In Commercial Distribution

  • 15099590538170 ()
6605015

  • Multiple CD cell marker IVD, antibody

CYTO-STAT /COULTER CLONE CD3-PC5 - 15099590538156

CYTO-STAT /COULTER CLONE CD3-PC5 (Analyte Specific Reagent)
Beckman Coulter, Inc.
6607010
In Commercial Distribution

  • 15099590538156 ()
6607010

  • Multiple CD cell marker IVD, antibody

CS/CC MsIgG1-RD1/ MsIgG2a-FITC - 15099590537326

CYTO-STAT/COULTER CLONE MsIgG1-RD1/MsIgG2a-FITC
Beckman Coulter, Inc.
6603795
In Commercial Distribution

  • 15099590537326 ()
6603795

  • Multiple CD cell marker IVD, control

CYTO-STAT/COULTER CLONE T8-FITC/NKH-1-RD1 - 15099590537302

CYTO-STAT/COULTER CLONE T8-FITC/NKH-1-RD1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
6603798
In Commercial Distribution

  • 15099590537302 ()
6603798

  • Multiple CD cell marker IVD, antibody

CYTO-STAT/COULTER CLONE T4-FITC/4B4-RD1 - 15099590537296

CYTO-STAT/COULTER CLONE T4-FITC/4B4-RD1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
6603799
In Commercial Distribution

  • 15099590537296 ()
6603799

  • Multiple CD cell marker IVD, antibody

CC B1-RD1 - 15099590537067

COULTER CLONE B1-RD1
Beckman Coulter, Inc.
6603446
In Commercial Distribution

  • 15099590537067 ()
6603446

  • Multiple CD cell marker IVD, antibody

CC MY4-RD1 - 15099590537036

COULTER CLONE MY4-RD1
Beckman Coulter, Inc.
6603262
In Commercial Distribution

  • 15099590537036 ()
6603262

  • Multiple CD cell marker IVD, antibody

CC Mo2-RD1 - 15099590537029

COULTER CLONE Mo2-RD1
Beckman Coulter, Inc.
6603266
In Commercial Distribution

  • 15099590537029 ()
6603266

  • Multiple CD cell marker IVD, antibody

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

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
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