Cell-Free DNA BCT
Streck, Inc.
Streck, Inc.
PMN#
GUDID#
Cal-Chex A Plus - A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 1 vial.
2016-09-16
Cal-Chex A Plus - A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 2 vials.
2016-09-16
Cal-Chex A Plus - A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 2 vials.
2016-09-16
STaK-Chex Plus Retics - A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials of normal level.
2016-09-19
CVA - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5.
2016-09-16
CVA - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-4, PLT L1-4.
2016-09-16
CVA - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-4, WBC L1-4, PLT L1-4.
2016-09-16
CVA - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-5, PLT L1-5.
2016-09-16
CVA - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-4, PLT L1-5.
2016-09-16
CVA - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-7, PLT L1-6
2016-09-16
CVA - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of WBC L1-7.
2016-09-16
CVA - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of PLT L1-6.
2016-09-16
CVA for CellDyn - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-4, WBC L1-4, PLT L1-4.
2016-09-16
CVA for CellDyn - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-5, PLT L1-6.
2016-09-16
CVA for CellDyn - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of WBC L1-5.
2016-09-16
CVA for CellDyn - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of PLT L1-6.
2016-09-16
CVA - Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-4, PLT L1-4.
2016-09-16
Cal-Chex - A hematology calibrator assayed for Beckman Coulter®, Abbott, Horiba Medical, HTI, and Mindray instruments. Contains 1 vial.
2016-09-16
Cal-Chex - A hematology calibrator assayed for Beckman Coulter®, Abbott, Horiba Medical, HTI, and Mindray instruments. Contains 3 vials.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of Normal level.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of CD4L level.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials Normal level.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials of CD4L level.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials Normal level.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials of CD4L level.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials Normal level.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of CD4L level.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials Normal level.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of CD4L level.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 8 vials Normal level.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of level Normal
2016-12-01
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of level CD4L
2016-12-01
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial each of levels CD4L and Normal.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials each of levels CD4L and Normal.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials each of levels CD4L and Normal.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials each of levels CD4L and Normal.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials each of levels CD4L and Normal.
2016-09-16
CD-Chex Plus - A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial each of levels CD4L and Normal.
2016-09-16
MDx-Chex for BC-GN - MDx-Chex™ for BC-GN is intended for use as an external positive and negative assayed control to monitorthe performance of the qualitative detection of Gram-Negative bacteria and associated antimicrobialresistance genes, by the Luminex VERIGENE® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) onLuminex VERIGENE® systems. The MDx-Chex™ for BC-GN Positive and Negative Controls are composedof a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture mediacomponents. Positive Control: Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Klebsiellaoxytoca, Pseudomonas aeruginosa, Species: Acinetobacter spp., Citrobacter spp., Enterobacter spp., Proteusspp.; antimicrobial resistance genes: CTX-M, IMP, KPC, NDM, OXA and VIM. Negative Control: bufferedsolution only. This product is not intended to replace manufacturer controls provided with the device.
2023-08-09
MDx-Chex for BC-GP - MDx-Chex™ for BC-GP is intended for use as an external positive and negative assayed control to monitor theperformance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistancegenes, by the Luminex VERIGENE® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on LuminexVERIGENE® systems. The MDx-Chex™ for BC-GP Positive and Negative Controls are composed of a bufferedsolution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components.Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcuslugdunensis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis,Enterococcus faecium, Streptococcus anginosus group; Species: Staphylococcus spp., Streptococcus spp., Listeria spp.;antimicrobial resistance genes: mecA, vanA and vanB. Negative Control: buffered solution only. This productis not intended to replace manufacturer controls provided with the device.
2023-08-09