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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COULTER CLONE MsIgG2a
Beckman Coulter, Inc.
6602876
In Commercial Distribution

  • 15099590542528 ()
6602876

  • Multiple CD cell marker IVD, control
COULTER CLONE MsIgG1-RD1
Beckman Coulter, Inc.
6602884
In Commercial Distribution

  • 15099590542511 ()
6602884

  • Multiple CD cell marker IVD, control
COULTER CLONE MsIgG2a-RD1
Beckman Coulter, Inc.
6602888
In Commercial Distribution

  • 15099590542504 ()
6602888

  • Multiple CD cell marker IVD, control
CYTO-STAT /COULTER CLONE CD16-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6604894
In Commercial Distribution

  • 15099590542498 ()
6604894

  • Multiple CD cell marker IVD, antibody
CYTO-STAT /COULTER CLONE CD38-RD1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
6604928
In Commercial Distribution

  • 15099590542481 ()
6604928

  • Multiple CD cell marker IVD, antibody
CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC/T4-RD1
Beckman Coulter, Inc.
6604929
In Commercial Distribution

  • 15099590542474 ()
6604929

  • Multiple CD cell marker IVD, antibody
COULTER CLONE 3A1-RD1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
6603827
In Commercial Distribution

  • 15099590542405 ()
6603827

  • Multiple CD cell marker IVD, antibody
COULTER CLONE KC56 (T-200)-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6603838
In Commercial Distribution

  • 15099590542399 ()
6603838

  • Multiple CD cell marker IVD, antibody
COULTER CLONE KC56 (T-200)-RD1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
6603839
In Commercial Distribution

  • 15099590542382 ()
6603839

  • Multiple CD cell marker IVD, antibody
CYTO-STAT/COULTER CLONE B4-RD1
Beckman Coulter, Inc.
6603846
In Commercial Distribution

  • 15099590542375 ()
6603846

  • Multiple CD cell marker IVD, antibody
CYTO-STAT/COULTER CLONE T8-RD1
Beckman Coulter, Inc.
6603848
In Commercial Distribution

  • 15099590542368 ()
6603848

  • Multiple CD cell marker IVD, antibody
CYTO-STAT/COULTER CLONE T11-RD1
Beckman Coulter, Inc.
6603849
In Commercial Distribution

  • 15099590542351 ()
6603849

  • Multiple CD cell marker IVD, antibody
CYTO-STAT/COULTER CLONE T4-RD1
Beckman Coulter, Inc.
6603850
In Commercial Distribution

  • 15099590542344 ()
6603850

  • Multiple CD cell marker IVD, antibody
CYTO-STAT/COULTER CLONE MsIgG2b-RD1 Isotopic Control (Analyte Specific Reagent)
Beckman Coulter, Inc.
6603852
In Commercial Distribution

  • 15099590542337 ()
6603852

  • Multiple CD cell marker IVD, antibody
CYTO-STAT/COULTER CLONE MsIgG2b-FITC
Beckman Coulter, Inc.
6603853
In Commercial Distribution

  • 15099590542320 ()
6603853

  • Multiple CD cell marker IVD, control
CYTO-STAT /COULTER CLONE T4-ECD (Analyte Specific Reagent)
Beckman Coulter, Inc.
6604727
In Commercial Distribution

  • 15099590542153 ()
6604727

  • Multiple CD cell marker IVD, antibody
CYTO-STAT /COULTER CLONE T8-ECD (Analyte Specific Reagent)
Beckman Coulter, Inc.
6604728
In Commercial Distribution

  • 15099590542146 ()
6604728

  • Multiple CD cell marker IVD, antibody
COULTER CLONE PLT-1-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6602993
In Commercial Distribution

  • 15099590542047 ()
6602993

  • Multiple CD cell marker IVD, antibody
COULTER CLONE MsIgG2b
Beckman Coulter, Inc.
6603001
In Commercial Distribution

  • 15099590542030 ()
6603001

  • Multiple CD cell marker IVD, control
COULTER CLONE B4-FITC
Beckman Coulter, Inc.
6603012
In Commercial Distribution

  • 15099590542023 ()
6603012

  • Multiple CD cell marker IVD, antibody
COULTER CLONE T1-RD1
Beckman Coulter, Inc.
6603020
In Commercial Distribution

  • 15099590542016 ()
6603020

  • Multiple CD cell marker IVD, antibody
COULTER CLONE B4-RD1
Beckman Coulter, Inc.
6603024
In Commercial Distribution

  • 15099590542009 ()
6603024

  • Multiple CD cell marker IVD, antibody
COULTER CLONE NKH-1-RD1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
6603067
In Commercial Distribution

  • 15099590541996 ()
6603067

  • Multiple CD cell marker IVD, antibody
CYTO-STAT /COULTER CLONE B4 (Lytic)-RD1/J5-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6604241
In Commercial Distribution

  • 15099590541989 ()
6604241

  • Multiple CD cell marker IVD, antibody
COULTER CYTO-TROL Control Cells Kit
Beckman Coulter, Inc.
6604248
In Commercial Distribution

  • 15099590541972 ()
6604248

  • Multiple CD cell marker IVD, control
COULTER CLONE MsIgG2b-RD1
Beckman Coulter, Inc.
6603038
In Commercial Distribution

  • 15099590541941 ()
6603038

  • Multiple CD cell marker IVD, control
COULTER CLONE MY9-RD1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
6603042
In Commercial Distribution

  • 15099590541934 ()
6603042

  • Multiple CD cell marker IVD, antibody
COULTER CLONE J5-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6602463
In Commercial Distribution

  • 15099590541606 ()
6602463

  • Multiple CD cell marker IVD, antibody
COULTER CLONE B1-FITC
Beckman Coulter, Inc.
6602381
In Commercial Distribution

  • 15099590540951 ()
6602381

  • Multiple CD cell marker IVD, antibody
CYTO-STAT /COULTER CLONE MY9-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6604111
In Commercial Distribution

  • 15099590540937 ()
6604111

  • Multiple CD cell marker IVD, antibody
FlowCARE PLG CD4 Reagent (CD45-FITC/CD4-PE)
Beckman Coulter, Inc.
627808
In Commercial Distribution

  • 15099590540890 ()
627808

  • Multiple CD cell marker IVD, antibody
CYTO-STAT/COULTER CLONE MsIgM-RD1/MsIgG1-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6603914
In Commercial Distribution

  • 15099590540876 ()
6603914

  • Multiple CD cell marker IVD, antibody
CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC
Beckman Coulter, Inc.
6603928
In Commercial Distribution

  • 15099590540869 ()
6603928

  • Multiple CD cell marker IVD, antibody
CYTO-STAT /COULTER CLONE KC56-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6604104
In Commercial Distribution

  • 15099590540852 ()
6604104

  • Multiple CD cell marker IVD, antibody
CYTO-STAT/COULTER CLONE B1-FITC
Beckman Coulter, Inc.
6604106
In Commercial Distribution

  • 15099590540838 ()
6604106

  • Multiple CD cell marker IVD, antibody
CYTO-STAT /COULTER CLONE J5-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6604107
In Commercial Distribution

  • 15099590540821 ()
6604107

  • Multiple CD cell marker IVD, antibody
CSYTO-STAT triCHROME MsIgG1-FITC/MsIgG1-RD1/MsIgG1-PC5
Beckman Coulter, Inc.
6607054
In Commercial Distribution

  • 15099590540814 ()
6607054

  • Multiple CD cell marker IVD, control
COULTER Manual CD4 Count Kit
Beckman Coulter, Inc.
6603876
In Commercial Distribution

  • 15099590540807 ()
6603876

  • Multiple CD cell marker IVD, antibody
CYTO-STAT/COULTER CLONE MsIgM-FITC
Beckman Coulter, Inc.
6603877
In Commercial Distribution

  • 15099590540791 ()
6603877

  • Multiple CD cell marker IVD, control
CYTO-STAT/COULTER CLONE T4-FITC
Beckman Coulter, Inc.
6603862
In Commercial Distribution

  • 15099590540708 ()
6603862

  • Multiple CD cell marker IVD, antibody
CYTO-STAT/COULTER CLONE T11-FITC
Beckman Coulter, Inc.
6603863
In Commercial Distribution

  • 15099590540692 ()
6603863

  • Multiple CD cell marker IVD, antibody
CYTO-STAT/COULTER CLONE MsIgG1-FITC
Beckman Coulter, Inc.
6603864
In Commercial Distribution

  • 15099590540685 ()
6603864

  • Multiple CD cell marker IVD, control
CYTO-STAT triCHROME CD8-FITC/CD4-RD1/CD3-PC5
Beckman Coulter, Inc.
6607053
In Commercial Distribution

  • 15099590540531 ()
6607053

  • Multiple CD cell marker IVD, antibody
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
Beckman Coulter, Inc.
6607077
In Commercial Distribution

  • 15099590540449 ()
6607077

  • Multiple CD cell marker IVD, control
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
CYTO-STAT triCHROME CD45-FITC/CD4-RD1/CD3-PC5
Beckman Coulter, Inc.
6607015
In Commercial Distribution

  • 15099590540418 ()
6607015

  • Multiple CD cell marker IVD, antibody
CYTO-STAT triCHROME CD45-FITC/CD8-RD1/CD3-PC5
Beckman Coulter, Inc.
6607017
In Commercial Distribution

  • 15099590540401 ()
6607017

  • Multiple CD cell marker IVD, antibody
ClearLLab 10C M2 Cell Tube
BECKMAN COULTER IRELAND INC.
B96808
In Commercial Distribution

  • 15099590701505 ()


  • Multiple CD cell marker IVD, antibody
ClearLLab 10C M1 Cell Tube
BECKMAN COULTER IRELAND INC.
B96807
In Commercial Distribution

  • 15099590701499 ()


  • Multiple CD cell marker IVD, antibody
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