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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 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

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 CD3(IgG1) - 15099590207069

COULTER CLONE CD3(IgG1) (Analyte Specific Reagent)
Beckman Coulter, Inc.
A83481
In Commercial Distribution

  • 15099590207069 ()
A83481

  • 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

COULTER CLONE T4 - 15099590207045

COULTER CLONE T4 (Analyte Specific Reagent)
Beckman Coulter, Inc.
A83479
In Commercial Distribution

  • 15099590207045 ()
A83479

  • Multiple CD cell marker IVD, antibody

COULTER CLONE B4 - 15099590207038

COULTER CLONE B4 (Analyte Specific Reagent)
Beckman Coulter, Inc.
A83478
In Commercial Distribution

  • 15099590207038 ()
A83478

  • Multiple CD cell marker IVD, antibody

COULTER CLONE B1 - 15099590207021

COULTER CLONE B1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
A83477
In Commercial Distribution

  • 15099590207021 ()
A83477

  • Multiple CD cell marker IVD, antibody

FlowCARE TLG Reagent - 15099590204549

FlowCARE TLG Reagent
Beckman Coulter, Inc.
A54927
In Commercial Distribution

  • 15099590204549 ()
A54927

  • Multiple CD cell marker IVD, antibody

ClearLLab 10C - 15099590701505

ClearLLab 10C M2 Cell Tube
BECKMAN COULTER IRELAND INC.
B96808
In Commercial Distribution

  • 15099590701505 ()


  • Multiple CD cell marker IVD, antibody

ClearLLab 10C - 15099590701499

ClearLLab 10C M1 Cell Tube
BECKMAN COULTER IRELAND INC.
B96807
In Commercial Distribution

  • 15099590701499 ()


  • Multiple CD cell marker IVD, antibody

ClearLLab 10C - 15099590701482

ClearLLab 10C T Cell Tube
BECKMAN COULTER IRELAND INC.
B96806
In Commercial Distribution

  • 15099590701482 ()


  • Multiple CD cell marker IVD, antibody

ClearLLab 10C - 15099590701475

ClearLLab 10C B Cell Tube
BECKMAN COULTER IRELAND INC.
B96805
In Commercial Distribution

  • 15099590701475 ()


  • Multiple CD cell marker IVD, antibody

ClearLLab 10C - 15099590694982

ClearLLab Compensation Beads
BECKMAN COULTER IRELAND INC.
B99883
In Commercial Distribution

  • 15099590694982 ()


  • Multiple CD cell marker IVD, antibody

ClearLLab 10C - 15099590694975

ClearLLab Control Cells abnormal
BECKMAN COULTER IRELAND INC.
B90003
In Commercial Distribution

  • 15099590694975 ()


  • Multiple CD cell marker IVD, control

ClearLLab 10C - 15099590694968

ClearLLab 10C Control Cells normal
BECKMAN COULTER IRELAND INC.
B90002
In Commercial Distribution

  • 15099590694968 ()


  • Multiple CD cell marker IVD, control

CYTO-STAT /COULTER CLONE Mo2-RD1 - 15099590672546

CYTO-STAT /COULTER CLONE Mo2-RD1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
B36634
In Commercial Distribution

  • 15099590672546 ()
B36634

  • Multiple CD cell marker IVD, antibody

CYTO-STAT /COULTER CLONE MsIgG2a-RD1 - 15099590672539

CYTO-STAT /COULTER CLONE MsIgG2a-RD1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
B36633
In Commercial Distribution

  • 15099590672539 ()
B36633

  • Multiple CD cell marker IVD, antibody

CYTO-STAT /COULTER CLONE Mo2-FITC - 15099590672522

CYTO-STAT /COULTER CLONE Mo2-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
B36631
In Commercial Distribution

  • 15099590672522 ()
B36631

  • Multiple CD cell marker IVD, antibody

CYTO-STAT /COULTER CLONE My4-FITC - 15099590672515

CYTO-STAT /COULTER CLONE My4-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
B36630
In Commercial Distribution

  • 15099590672515 ()
B36630

  • Multiple CD cell marker IVD, antibody

CYTO-STAT /COULTER CLONE MsIgM-FITC - 15099590672508

CYTO-STAT /COULTER CLONE MsIgM-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
B36627
In Commercial Distribution

  • 15099590672508 ()
B36627

  • Multiple CD cell marker IVD, antibody

CYTO-STAT /COULTER CLONE B1-FITC - 15099590672492

CYTO-STAT /COULTER CLONE B1-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
B36626
In Commercial Distribution

  • 15099590672492 ()
B36626

  • Multiple CD cell marker IVD, antibody

CYTO-STAT /COULTER CLONE B1-RD1 - 15099590672485

CYTO-STAT /COULTER CLONE B1-RD1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
B36625
In Commercial Distribution

  • 15099590672485 ()
B36625

  • Multiple CD cell marker IVD, antibody
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