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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 each of low, normal & high levels.
STRECK, INC.
225512
In Commercial Distribution

  • 00844509001188 ()

  • Total Volume: 4.0 Milliliter
225512

  • Full blood count IVD, control
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 1 vial each of low, normal & high levels.
STRECK, INC.
225503
In Commercial Distribution

  • 00844509001171 ()

  • Total Volume: 4.0 Milliliter
225503

  • Full blood count IVD, control
Retic-Chex Linearity BC is designed to establish the patient reportable range and linearity of the system. Contains 1 vial each of levels 1-5.
STRECK, INC.
285535
In Commercial Distribution

  • 00844509001133 ()

  • Total Volume: 3.0 Milliliter
285535

  • Reticulocyte count IVD, control
Retic-Chex Linearity is designed to establish the patient reportable range and linearity of the system. Contains 1 vial each of levels 1-5.
STRECK, INC.
285633
In Commercial Distribution

  • 00844509001072 ()

  • Total Volume: 2.5 Milliliter
285633

  • Reticulocyte count IVD, control
Retic-Chex Linearity is designed to establish the patient reportable range and linearity of the system. Contains 1 vial each of levels 1-5.
STRECK, INC.
285532
In Commercial Distribution

  • 00844509001065 ()

  • Total Volume: 2.5 Milliliter
285532

  • Reticulocyte count IVD, control
A1c-Cellular Linearity contains one vial each of Levels 1-5. A1c-Cellular Linearity assesses the accuracy and linear reportable range of the HbA1c parameter.
STRECK, INC.
285536
In Commercial Distribution

  • 00844509001003 ()

  • Total Volume: 2.0 Milliliter
285536

  • Glycated haemoglobin (HbA1c) IVD, control
A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains one vial each of Level 1 and 2.
STRECK, INC.
211130
In Commercial Distribution

  • 00844509000945 ()

  • Total Volume: 2.0 Milliliter
211130

  • Glycated haemoglobin (HbA1c) IVD, control
A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains 3 vials each of Level 1 and 2.
STRECK, INC.
211124
In Commercial Distribution

  • 00844509000938 ()

  • Total Volume: 2.0 Milliliter
211124

  • Glycated haemoglobin (HbA1c) IVD, control
A positive and negative whole blood control to test for the presence of Hemoglobin S in solubility tests and hemoglobin electrophoresis. Contains 2 each of P+ & N-
STRECK, INC.
217654
In Commercial Distribution

  • 00844509000891 ()

  • Total Volume: 2.5 Milliliter
217654

  • Haemoglobin S (HbS) IVD, control
A positive and negative whole blood control to test for the presence of Hemoglobin S in solubility tests and hemoglobin electrophoresis. Contains 1 each of P+ & N-
STRECK, INC.
217653
In Commercial Distribution

  • 00844509000884 ()

  • Total Volume: 2.5 Milliliter
217653

  • Haemoglobin S (HbS) IVD, control
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 4 vials each of normal & high levels.
STRECK, INC.
215428
In Commercial Distribution

  • 00844509000815 ()

  • Total Volume: 1.5 Milliliter
215428

  • 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 6 vials each of low, normal & high levels.
STRECK, INC.
215418
In Commercial Distribution

  • 00844509000808 ()

  • Total Volume: 1.5 Milliliter
215418

  • 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 4 vials each of low, normal & high levels.
STRECK, INC.
215412
In Commercial Distribution

  • 00844509000792 ()

  • Total Volume: 1.5 Milliliter
215412

  • 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 4 vials each of low & high levels.
STRECK, INC.
215409
In Commercial Distribution

  • 00844509000785 ()

  • Total Volume: 1.5 Milliliter
215409

  • 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 4 vials each of low & normal levels.
STRECK, INC.
215408
In Commercial Distribution

  • 00844509000778 ()

  • Total Volume: 1.5 Milliliter
215408

  • 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 2 vials each of low & normal levels.
STRECK, INC.
215406
In Commercial Distribution

  • 00844509000761 ()

  • Total Volume: 1.5 Milliliter
215406

  • 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.
215403
In Commercial Distribution

  • 00844509000754 ()

  • Total Volume: 1.5 Milliliter
215403

  • 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 4 vials each of normal & high levels.
STRECK, INC.
215115
In Commercial Distribution

  • 00844509000747 ()

  • Total Volume: 1.5 Milliliter
215115

  • 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 4 vials each of low & normal levels.
STRECK, INC.
215112
In Commercial Distribution

  • 00844509000730 ()

  • Total Volume: 1.5 Milliliter
215112

  • 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 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
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