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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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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

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

CC MsIgG1-FITC - 15099590542870

COULTER CLONE MsIgG1-FITC
Beckman Coulter, Inc.
6602928
In Commercial Distribution

  • 15099590542870 ()
6602928

  • Multiple CD cell marker IVD, control

CC MsIgM-RD1 - 15099590542863

COULTER CLONE MsIgM-FITC
Beckman Coulter, Inc.
6602940
In Commercial Distribution

  • 15099590542863 ()
6602940

  • Multiple CD cell marker IVD, control

COULTER CLONE MY7-RD1 - 15099590542849

COULTER CLONE MY7-RD1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
6602989
In Commercial Distribution

  • 15099590542849 ()
6602989

  • Multiple CD cell marker IVD, antibody

CC MsIgG2a-FITC - 15099590542719

COULTER CLONE MsIgG2a-FITC
Beckman Coulter, Inc.
6602906
In Commercial Distribution

  • 15099590542719 ()
6602906

  • Multiple CD cell marker IVD, control

CYTO-STAT /COULTER CLONE I3-RD1 - 15099590542665

CYTO-STAT /COULTER CLONE I3-RD1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
6604366
In Commercial Distribution

  • 15099590542665 ()
6604366

  • Multiple CD cell marker IVD, antibody

COULTER CLONE B6-FITC - 15099590542658

COULTER CLONE B6-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6604368
In Commercial Distribution

  • 15099590542658 ()
6604368

  • Multiple CD cell marker IVD, antibody

CS/CC CD3(IgG1)-FITC - 15099590542603

CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC
Beckman Coulter, Inc.
6604623
In Commercial Distribution

  • 15099590542603 ()
6604623

  • Multiple CD cell marker IVD, antibody

CC CD3(IgG1)-FITC - 15099590542597

COULTER CLONE CD3(IgG1)-FITC
Beckman Coulter, Inc.
6604625
In Commercial Distribution

  • 15099590542597 ()
6604625

  • Multiple CD cell marker IVD, antibody

CC CD3(IgG1)-RD1 - 15099590542580

COULTER CLONE CD3(IgG1)-RD1
Beckman Coulter, Inc.
6604627
In Commercial Distribution

  • 15099590542580 ()
6604627

  • Multiple CD cell marker IVD, antibody

CYTO-STAT /COULTER CLONE MsIgG2b-ECD - 15099590542559

CYTO-STAT /COULTER CLONE MsIgG2b-ECD (Analyte Specific Reagent)
Beckman Coulter, Inc.
6604700
In Commercial Distribution

  • 15099590542559 ()
6604700

  • Multiple CD cell marker IVD, antibody

CC T11-RD1 (CD2-RD1) - 15099590542542

COULTER CLONE T11-RD1
Beckman Coulter, Inc.
6602868
In Commercial Distribution

  • 15099590542542 ()
6602868

  • Multiple CD cell marker IVD, antibody

CC MsIgG1 Isotypic Control - 15099590542535

COULTER CLONE MsIgG1
Beckman Coulter, Inc.
6602872
In Commercial Distribution

  • 15099590542535 ()
6602872

  • Multiple CD cell marker IVD, control

CC MsIgG2a - 15099590542528

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

  • 15099590542528 ()
6602876

  • Multiple CD cell marker IVD, control

CC MsIgG1-RD1 - 15099590542511

COULTER CLONE MsIgG1-RD1
Beckman Coulter, Inc.
6602884
In Commercial Distribution

  • 15099590542511 ()
6602884

  • Multiple CD cell marker IVD, control

CC MsIgG2a-RD1 - 15099590542504

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 - 15099590542498

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 - 15099590542481

CYTO-STAT /COULTER CLONE CD38-RD1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
6604928
In Commercial Distribution

  • 15099590542481 ()
6604928

  • Multiple CD cell marker IVD, antibody

CS/CC CD3(IgG1)-FITC/T4-RD1 - 15099590542474

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 - 15099590542405

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 - 15099590542399

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 - 15099590542382

COULTER CLONE KC56 (T-200)-RD1 (Analyte Specific Reagent)
Beckman Coulter, Inc.
6603839
In Commercial Distribution

  • 15099590542382 ()
6603839

  • Multiple CD cell marker IVD, antibody

CS/CC B4-RD1 - 15099590542375

CYTO-STAT/COULTER CLONE B4-RD1
Beckman Coulter, Inc.
6603846
In Commercial Distribution

  • 15099590542375 ()
6603846

  • Multiple CD cell marker IVD, antibody

CS/CC T8-RD1 (CD8-RD1) - 15099590542368

CYTO-STAT/COULTER CLONE T8-RD1
Beckman Coulter, Inc.
6603848
In Commercial Distribution

  • 15099590542368 ()
6603848

  • Multiple CD cell marker IVD, antibody

CS/CC T11-RD1 (CD2-RD1) - 15099590542351

CYTO-STAT/COULTER CLONE T11-RD1
Beckman Coulter, Inc.
6603849
In Commercial Distribution

  • 15099590542351 ()
6603849

  • Multiple CD cell marker IVD, antibody

CS/CC T4-RD1 (CD4-RD1) - 15099590542344

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 - 15099590542337

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

CS/CC MsIgG2b-FITC - 15099590542320

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 - 15099590542153

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 - 15099590542146

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 - 15099590542047

COULTER CLONE PLT-1-FITC (Analyte Specific Reagent)
Beckman Coulter, Inc.
6602993
In Commercial Distribution

  • 15099590542047 ()
6602993

  • Multiple CD cell marker IVD, antibody
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