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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 whole blood assayed hematology control that offers complete assay values for the 5-part white cell differential available with Beckman Coulter STKS™, MAXM™, HmX and LH 500. Contains 4 vials of low level.
STRECK, INC.
225524
In Commercial Distribution

  • 20844509001144 ()

  • Total Volume: 4.0 Milliliter
225524

  • Full blood count IVD, control
Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 3 vials of level 3.
STRECK, INC.
200069
In Commercial Distribution

  • 20844509000574 ()

  • Total Volume: 3.0 Milliliter
200069

  • Full blood count IVD, control
Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 3 vials of level 2.
STRECK, INC.
200068
In Commercial Distribution

  • 20844509000567 ()

  • Total Volume: 3.0 Milliliter
200068

  • Full blood count IVD, control
Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 3 vials of level 1.
STRECK, INC.
200067
In Commercial Distribution

  • 20844509000550 ()

  • Total Volume: 3.0 Milliliter
200067

  • Full blood count IVD, control
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
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
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
Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 6 vials of L2.
STRECK, INC.
212424
In Commercial Distribution

  • 20844509000277 ()

  • Total Volume: 2.0 Milliliter
212424

  • Full blood count IVD, control
Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 2 vials of L1-CC.
STRECK, INC.
212429
In Commercial Distribution

  • 20844509000260 ()

  • Total Volume: 2.0 Milliliter
212429

  • Full blood count IVD, control
Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 6 vials of L1-UC.
STRECK, INC.
212432
In Commercial Distribution

  • 20844509000253 ()

  • Total Volume: 2.0 Milliliter
212432

  • Full blood count IVD, control
A hematology calibrator assayed for Beckman Coulter®, Abbott, Horiba Medical, HTI, and Mindray instruments. Contains 1 vial.
STRECK, INC.
221101
In Commercial Distribution

  • 20844509000246 ()

  • Total Volume: 3.0 Milliliter
221101

  • Full blood count IVD, calibrator
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