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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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CD4 control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB51540 ()
BSB 5154

  • Multiple CD cell marker IVD, control
CD3 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB51470 ()
BSB 5147

  • Multiple CD cell marker IVD, control
CD1a Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB51400 ()
BSB 5140

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of CD4L level.
STRECK, INC.
213330
In Commercial Distribution

  • 10844509000096 ()

  • Total Volume: 2.5 Milliliter
213330

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of Normal level.
STRECK, INC.
213325
In Commercial Distribution

  • 10844509000089 ()

  • Total Volume: 2.5 Milliliter
213325

  • Multiple CD cell marker IVD, control
Circulating Tumor Cell Control Cell Kit
MENARINI SILICON BIOSYSTEMS, INC.
7900003
In Commercial Distribution

  • 10888385000023 ()
  • 80888385000022 ()
7900003

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials each of CD4L and Normal level.
STRECK, INC.
213376
In Commercial Distribution

  • 00844509000549 ()

  • Total Volume: 3.0 Milliliter
213376

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials each of CD4L and Normal level.
STRECK, INC.
213375
Not in Commercial Distribution

  • 00844509000532 ()

  • Total Volume: 3.0 Milliliter
213375

  • Multiple CD cell marker IVD, control
A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 2 vials each of level 1 and 2.
STRECK, INC.
213339
In Commercial Distribution

  • 00844509000501 ()

  • Total Volume: 1.0 Milliliter
213339

  • Multiple CD cell marker IVD, control
A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 1 vial each of level 1 and 2.
STRECK, INC.
213338
In Commercial Distribution

  • 00844509000495 ()

  • Total Volume: 1.0 Milliliter
213338

  • Multiple CD cell marker IVD, control
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