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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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Langerin Control Slides - B502BSB9257CS0

Langerin Control Slides
BIO SB, INC.
BSB-9257-CS
In Commercial Distribution

  • B502BSB9257CS0 ()
BSB-9257-CS

  • Multiple CD cell marker IVD, control

CD-Chex Plus BC - 20844509000529

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of Normal level.
STRECK, INC.
213371
In Commercial Distribution

  • 20844509000529 ()

  • Total Volume: 3.0 Milliliter
213371

  • Multiple CD cell marker IVD, control

CD-Chex Plus BC - 20844509000512

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of Normal level.
STRECK, INC.
213373
In Commercial Distribution

  • 20844509000512 ()

  • Total Volume: 3.0 Milliliter
213373

  • Multiple CD cell marker IVD, control

CD-Chex CD34 - 20844509000482

A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 1 vial of level 3.
STRECK, INC.
213382
In Commercial Distribution

  • 20844509000482 ()

  • Total Volume: 1.0 Milliliter
213382

  • Multiple CD cell marker IVD, control

CD-Chex CD34 - 20844509000475

A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 1 vial of level 2.
STRECK, INC.
213346
In Commercial Distribution

  • 20844509000475 ()

  • Total Volume: 1.0 Milliliter
213346

  • Multiple CD cell marker IVD, control

CD-Chex CD34 - 20844509000468

A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 1 vial of level 1.
STRECK, INC.
213336
In Commercial Distribution

  • 20844509000468 ()

  • Total Volume: 1.0 Milliliter
213336

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 20844509000147

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials of CD4L level.
STRECK, INC.
213366
In Commercial Distribution

  • 20844509000147 ()

  • Total Volume: 3.0 Milliliter
213366

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 20844509000130

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials Normal level.
STRECK, INC.
213365
In Commercial Distribution

  • 20844509000130 ()

  • Total Volume: 3.0 Milliliter
213365

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 20844509000093

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials of CD4L level.
STRECK, INC.
213331
In Commercial Distribution

  • 20844509000093 ()

  • Total Volume: 2.5 Milliliter
213331

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 20844509000086

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials Normal level.
STRECK, INC.
213326
In Commercial Distribution

  • 20844509000086 ()

  • Total Volume: 2.5 Milliliter
213326

  • Multiple CD cell marker IVD, control

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

CS/CC MsIgG1-RD1/ MsIgG1-FITC - 15099590537319

CYTO-STAT/COULTER CLONE MsIgG1-RD1/MsIgG1-FITC
Beckman Coulter, Inc.
6603796
In Commercial Distribution

  • 15099590537319 ()
6603796

  • Multiple CD cell marker IVD, control

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 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

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
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