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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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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
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
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
A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 4 vials of level 3.
STRECK, INC.
285304
In Commercial Distribution

  • 20844509000390 ()

  • Total Volume: 1.0 Milliliter
285304

  • Reticulocyte count IVD, control
A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 4 vials of level 2.
STRECK, INC.
285204
In Commercial Distribution

  • 20844509000383 ()

  • Total Volume: 1.0 Milliliter
285204

  • Reticulocyte count IVD, control
A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 4 vials of level 1.
STRECK, INC.
285104
In Commercial Distribution

  • 20844509000376 ()

  • Total Volume: 1.0 Milliliter
285104

  • Reticulocyte count IVD, control
A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials of high level.
STRECK, INC.
225482
In Commercial Distribution

  • 20844509000345 ()

  • Total Volume: 4.5 Milliliter
225482

  • Full blood count IVD, control
A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials of normal level.
STRECK, INC.
225481
In Commercial Distribution

  • 20844509000338 ()

  • Total Volume: 4.5 Milliliter
225481

  • Full blood count IVD, control
A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials of low level.
STRECK, INC.
225480
In Commercial Distribution

  • 20844509000321 ()

  • Total Volume: 4.5 Milliliter
225480

  • Full blood count IVD, control
A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 1 vial.
STRECK, INC.
221106
In Commercial Distribution

  • 20844509000314 ()

  • Total Volume: 3.0 Milliliter
221106

  • Full blood count IVD, calibrator
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