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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 multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 2 vials each of low & normal levels.
STRECK, INC.
215110
In Commercial Distribution

  • 00844509000723 ()

  • Total Volume: 1.5 Milliliter
215110

  • Full blood count IVD, control
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 1 vial each of low, normal & high levels.
STRECK, INC.
215103
In Commercial Distribution

  • 00844509000716 ()

  • Total Volume: 1.5 Milliliter
215103

  • Full blood count IVD, control
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial each of low, normal & high levels.
STRECK, INC.
218776
In Commercial Distribution

  • 00844509000679 ()

  • Total Volume: 4.5 Milliliter
218776

  • Full blood count IVD, control
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 6 vials each of low, normal & high levels.
STRECK, INC.
218770
In Commercial Distribution

  • 00844509000662 ()

  • Total Volume: 4.5 Milliliter
218770

  • Full blood count IVD, control
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial each of low, normal & high levels.
STRECK, INC.
218755
In Commercial Distribution

  • 00844509000655 ()

  • Total Volume: 2.5 Milliliter
218755

  • Full blood count IVD, control
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 6 vials each of low, normal & high levels.
STRECK, INC.
218750
In Commercial Distribution

  • 00844509000648 ()

  • Total Volume: 2.5 Milliliter
218750

  • 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 each of level 1 & 2.
STRECK, INC.
213479
In Commercial Distribution

  • 00844509000600 ()

  • Total Volume: 3.0 Milliliter
213479

  • 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 1 vial each of level 1, 2 & 3.
STRECK, INC.
200066
In Commercial Distribution

  • 00844509000594 ()

  • Total Volume: 3.0 Milliliter
200066

  • 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 1 vial each of level 2 & 3.
STRECK, INC.
200065
In Commercial Distribution

  • 00844509000587 ()

  • Total Volume: 3.0 Milliliter
200065

  • Full blood count 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
A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 1 vial each of level 1 & 2.
STRECK, INC.
285212
In Commercial Distribution

  • 00844509000457 ()

  • Total Volume: 1.0 Milliliter
285212

  • Reticulocyte count IVD, control
A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 1 vial each of level 1 & 3.
STRECK, INC.
285211
In Commercial Distribution

  • 00844509000440 ()

  • Total Volume: 1.0 Milliliter
285211

  • Reticulocyte count IVD, control
A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 2 vials each of level 1, 2 & 3.
STRECK, INC.
285106
In Commercial Distribution

  • 00844509000433 ()

  • Total Volume: 1.0 Milliliter
285106

  • Reticulocyte count IVD, control
A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 1 vial each of level 1, 2 & 3 and 1 vial of stain.
STRECK, INC.
285101
In Commercial Distribution

  • 00844509000426 ()

  • Total Volume: 1.0 Milliliter
285101

  • Reticulocyte count IVD, control
A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 1 vial each of low, normal & high levels.
STRECK, INC.
225489
In Commercial Distribution

  • 00844509000365 ()

  • Total Volume: 4.5 Milliliter
225489

  • Full blood count IVD, control
A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials each of low, normal & high levels.
STRECK, INC.
225485
In Commercial Distribution

  • 00844509000358 ()

  • Total Volume: 4.5 Milliliter
225485

  • 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 1 vial each of L1-UC, L1-CC, LV2.
STRECK, INC.
212431
In Commercial Distribution

  • 00844509000303 ()

  • Total Volume: 2.0 Milliliter
212431

  • 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 each of L1-UC and L2.
STRECK, INC.
212425
In Commercial Distribution

  • 00844509000297 ()

  • Total Volume: 2.0 Milliliter
212425

  • 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 each of L1-UC and L2.
STRECK, INC.
212420
In Commercial Distribution

  • 00844509000280 ()

  • Total Volume: 2.0 Milliliter
212420

  • Full blood count IVD, control
A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 4 vials each of low, normal and high levels.
STRECK, INC.
218913
In Commercial Distribution

  • 00844509000235 ()

  • Total Volume: 3.0 Milliliter
218913

  • Full blood count IVD, control
A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 2 vials each of low, normal and high levels.
STRECK, INC.
218907
In Commercial Distribution

  • 00844509000228 ()

  • Total Volume: 3.0 Milliliter
218907

  • Full blood count IVD, control
A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 1 vial each of low, normal and high levels.
STRECK, INC.
218903
In Commercial Distribution

  • 00844509000211 ()

  • Total Volume: 3.0 Milliliter
218903

  • Full blood count IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial each of levels CD4L and Normal.
STRECK, INC.
213391
In Commercial Distribution

  • 00844509000174 ()

  • Total Volume: 3.0 Milliliter
213391

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials each of levels CD4L and Normal.
STRECK, INC.
213370
In Commercial Distribution

  • 00844509000167 ()

  • Total Volume: 3.0 Milliliter
213370

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials each of levels CD4L and Normal.
STRECK, INC.
213369
In Commercial Distribution

  • 00844509000150 ()

  • Total Volume: 3.0 Milliliter
213369

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials each of levels CD4L and Normal.
STRECK, INC.
213344
In Commercial Distribution

  • 00844509000129 ()

  • Total Volume: 2.5 Milliliter
213344

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials each of levels CD4L and Normal.
STRECK, INC.
213341
In Commercial Distribution

  • 00844509000112 ()

  • Total Volume: 2.5 Milliliter
213341

  • Multiple CD cell marker IVD, control
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