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 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
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
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial each of levels CD4L and Normal.
STRECK, INC.
213340
In Commercial Distribution

  • 00844509000105 ()

  • Total Volume: 2.5 Milliliter
213340

  • Multiple CD cell marker IVD, control
Lumipulse G B-Amyloid Controls (Plasma)-N
FUJIREBIO INC.
235485
Not in Commercial Distribution

  • 04987270235485 ()

  • 4 bottles per unit; 1.0mLs per bottle


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
Lumipulse G B-Amyloid 1-42-N Plasma IRC
FUJIREBIO INC.
235447
In Commercial Distribution

  • 04987270235447 ()

  • 42 Tests per Kit


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
Liquichek Diabetes Control Trilevel MiniPak (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
292X
In Commercial Distribution

  • 00847661004301 ()
292X

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 3 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
293
In Commercial Distribution

  • 00847661004295 ()
293

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 2 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
292
In Commercial Distribution

  • 00847661004288 ()
292

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 1 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
291
In Commercial Distribution

  • 00847661004271 ()
291

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level Trilevel MiniPak (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
172X
In Commercial Distribution

  • 00847661002192 ()
172X

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 3 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
173
In Commercial Distribution

  • 00847661000853 ()
173

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 2 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
172
In Commercial Distribution

  • 00847661000846 ()
172

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 1 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
171
In Commercial Distribution

  • 00847661000839 ()
171

  • Glycated haemoglobin (HbA1c) IVD, control
VERSANT® Tissue Preparation Reagents (Box 3)
Siemens Healthcare Diagnostics Inc.
10632400
Not in Commercial Distribution

  • 00630414588810 ()
10632400

  • Nucleic acid extraction/isolation kit IVD
UF ll CALIBRATOR
SYSMEX CORPORATION
06404310
In Commercial Distribution

  • 04987562408535 ()
  • 84987562408531 ()


  • Urine sediment IVD, calibrator
UF-CONTROL contains control particles for use in quality control measurement procedure of the Sysmex Fully Automated Urine Particle Analyzers and the Sysmex Fully Automated Urine Particle Digital Imaging Device.
SYSMEX CORPORATION
06404115
In Commercial Distribution

  • 04987562408528 ()

  • Total Volume: 47 Milliliter


  • Buffered sample diluent IVD
Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.)
ARKRAY USA, INC.
73806
In Commercial Distribution

  • 04987486738060 ()


  • Multiple urine analyte IVD, control
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