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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-RD1/B1-FITC - 15099590540869

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 - 15099590540852

CYTO-STAT /COULTER CLONE KC56-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6604104
In Commercial Distribution

  • 15099590540852 ()
6604104

  • Multiple CD cell marker IVD, antibody

CS/CC B1-FITC - 15099590540838

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 - 15099590540821

CYTO-STAT /COULTER CLONE J5-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6604107
In Commercial Distribution

  • 15099590540821 ()
6604107

  • Multiple CD cell marker IVD, antibody

CS triCHROME MsIgG1-FITC/MsIgG1-RD1/MsIgG1-PC5 - 15099590540814

CSYTO-STAT triCHROME MsIgG1-FITC/MsIgG1-RD1/MsIgG1-PC5
Beckman Coulter, Inc.
6607054
In Commercial Distribution

  • 15099590540814 ()
6607054

  • Multiple CD cell marker IVD, control

Manual CD4 Count Kit - 15099590540807

COULTER Manual CD4 Count Kit
Beckman Coulter, Inc.
6603876
In Commercial Distribution

  • 15099590540807 ()
6603876

  • Multiple CD cell marker IVD, antibody

CS/CC MsIgM-FITC - 15099590540791

CYTO-STAT/COULTER CLONE MsIgM-FITC
Beckman Coulter, Inc.
6603877
In Commercial Distribution

  • 15099590540791 ()
6603877

  • Multiple CD cell marker IVD, control

CS/CC T4-FITC - 15099590540708

CYTO-STAT/COULTER CLONE T4-FITC
Beckman Coulter, Inc.
6603862
In Commercial Distribution

  • 15099590540708 ()
6603862

  • Multiple CD cell marker IVD, antibody

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 triCHROME CD45-FITC/CD8-RD1/CD3-PC5 - 15099590540401

CYTO-STAT triCHROME CD45-FITC/CD8-RD1/CD3-PC5
Beckman Coulter, Inc.
6607017
In Commercial Distribution

  • 15099590540401 ()
6607017

  • Multiple CD cell marker IVD, antibody

CS triCHROME CD45-FITC/MsIgG1-RD1/MsIgG1-PC5 - 15099590540395

CYTO-STAT triCHROME CD45-FITC/MsIgG1-RD1/MsIgG1-PC5
Beckman Coulter, Inc.
6607019
In Commercial Distribution

  • 15099590540395 ()
6607019

  • Multiple CD cell marker IVD, control

CYTO-COMP REAGENT - 15099590540388

CYTO-COMP Reagent Kit
Beckman Coulter, Inc.
6607021
In Commercial Distribution

  • 15099590540388 ()
6607021

  • Multiple CD cell marker IVD, antibody

CYTO-COMP CELL KIT - 15099590540371

CYTO-COMP Cell Kit
Beckman Coulter, Inc.
6607023
In Commercial Distribution

  • 15099590540371 ()
6607023

  • Multiple CD cell marker IVD, control

CC T4-RD1 (CD4-RD1) - 15099590540319

COULTER CLONE T4-RD1
Beckman Coulter, Inc.
6602864
In Commercial Distribution

  • 15099590540319 ()
6602864

  • Multiple CD cell marker IVD, antibody

CS CD3-FITC/CD56-RD1 - 15099590540302

CYTO-STAT CD3-FITC/CD56-RD1
Beckman Coulter, Inc.
6607068
In Commercial Distribution

  • 15099590540302 ()
6607068

  • Multiple CD cell marker IVD, antibody

CS triCHROME CD45-FITC/CD19-RD1/CD3-PC5 - 15099590540289

CYTO-STAT triCHROME CD45-FITC/CD19-RD1/CD3-PC5
Beckman Coulter, Inc.
6607072
In Commercial Distribution

  • 15099590540289 ()
6607072

  • Multiple CD cell marker IVD, antibody

CS/CC Mo2-RD1 (CD14-RD1) - 15099590539757

CYTO-STAT/COULTER CLONE Mo2-RD1
Beckman Coulter, Inc.
6604500
In Commercial Distribution

  • 15099590539757 ()
6604500

  • Multiple CD cell marker IVD, antibody

CS/CC T8-RD1/T4-FITC (CD4-FITC/CD8-RD1) - 15099590539726

CYTO-STAT/COULTER CLONE T8-RD1/T4-FITC
Beckman Coulter, Inc.
6604614
In Commercial Distribution

  • 15099590539726 ()
6604614

  • Multiple CD cell marker IVD, antibody

COULTER CLONE IL-2R1-FITC - 15099590539634

COULTER CLONE IL-2R1-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6603200
In Commercial Distribution

  • 15099590539634 ()
6603200

  • Multiple CD cell marker IVD, antibody

CC T8-FITC (CD8-FITC) - 15099590539610

COULTER CLONE T8-FITC
Beckman Coulter, Inc.
6602385
In Commercial Distribution

  • 15099590539610 ()
6602385

  • 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

CD-Chex Plus BC - 30844509000519

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials of Normal level.
STRECK, INC.
213374
In Commercial Distribution

  • 30844509000519 ()

  • Total Volume: 3.0 Milliliter
213374

  • Multiple CD cell marker IVD, control

CD-Chex CD34 - 30844509000472

A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 2 vials of level 2.
STRECK, INC.
213347
In Commercial Distribution

  • 30844509000472 ()

  • Total Volume: 1.0 Milliliter
213347

  • Multiple CD cell marker IVD, control

CD-Chex CD34 - 30844509000465

A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 2 vials of level 1.
STRECK, INC.
213337
In Commercial Distribution

  • 30844509000465 ()

  • Total Volume: 1.0 Milliliter
213337

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 30844509000144

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of CD4L level.
STRECK, INC.
213368
In Commercial Distribution

  • 30844509000144 ()

  • Total Volume: 3.0 Milliliter
213368

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 30844509000137

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials Normal level.
STRECK, INC.
213367
In Commercial Distribution

  • 30844509000137 ()

  • Total Volume: 3.0 Milliliter
213367

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 30844509000090

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of CD4L level.
STRECK, INC.
213332
In Commercial Distribution

  • 30844509000090 ()

  • Total Volume: 2.5 Milliliter
213332

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 30844509000083

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials Normal level.
STRECK, INC.
213327
In Commercial Distribution

  • 30844509000083 ()

  • Total Volume: 2.5 Milliliter
213327

  • Multiple CD cell marker IVD, control
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