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The XR-Series module (XR-10) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XR-Series module classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, IPF#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal fluid (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected in K2EDTA or K3EDTA anticoagulant, and serous and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.

The Sysmex XR-Series module (XR-10) is a quantitative multi-parameter hematology analyzer intended to perform tests on whole blood samples collected in K2 or K3EDTA and body fluids (pleural, peritoneal and synovial) collected in K2EDTA anticoagulant. The analyzers can also perform tests on CSF, which should not be collected in any anticoagulant. The XR-Series analyzer consist of four principal units: (1) One Main Units (XR-10) which aspirates, dilutes, mixes, and analyzes blood and body fluid samples; (2) Two Auto Sampler Units (SA-10, SA-01) which supply samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system; (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit.

The XR-Series module (XR-20) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XR-Series module classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, IPF#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal fluid (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected in K2EDTA or K3EDTA anticoagulant, and serous and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.

The Sysmex XR-Series module (XR-20) is a quantitative multi-parameter hematology analyzer intended to perform tests on whole blood samples collected in K2 or K3EDTA and body fluids (pleural, peritoneal and synovial) collected in K2EDTA anticoagulant. The analyzers can also perform tests on CSF, which should not be collected in any anticoagulant. The XR-Series analyzer consist of four principal units: (1) One Main Unit (XR-20) which aspirates, dilutes, mixes, and analyzes blood and body fluid samples; (2) One Auto Sampler Unit which supply samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system; (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit. The XR-20 analyzer has an additional white progenitor cell (WPC) measuring channel and associated WPC reagents. The new WPC channel provides two separate flags for blasts and abnormal lymphocytes.

The Alinity h-series System is an integrated hematology analyzer (Alinity hq) and slide maker stainer (Alinity hs) intended for screening patient populations found in clinical laboratories by qualified health care professionals. The Alinity h-series can be configured as: · One stand-alone automated hematology analyzer system. · A multimodule system that includes at least one Alinity hg analyzer module and may include one Alinity hs slide maker stainer module. The Alinity hq analyzer module provides complete blood count and a 6-part white blood cell differential for normal and abnormal cells in capillary and venous whole blood collected in K2EDTA. The Alinity hq analyzer provides quantitative results for the following measurands: WBC, NEU, %N, LYM, %M, EOS, %E, BASO, %B, IG, %IG, RBC, HCT, HGB, MCV, MCH, MCHC, MCHr, RDW, NRBC, NR/W, RETIC, %R, IRF, PLT, MPV, %rP. The Almity hq analyzer module is indicated to identify patients with hematologic parameters within and outside of established reference ranges. The Alinity hs slide maker stainer module automates whole blood film preparation and staining and stains externally prepared whole blood smears. For in vitro diagnostic use.

The Alinity h-series System is a multimodule system that consists of different combinations of one or more of the following modules: a quantitative multi-parameter automated hematology analyzer (Alinity hg) and an automated slide maker stainer (Alinity hs). The Alinity hq is a quantitative, multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in counting and characterizing blood cells using a multi-angle polarized scattered separation (MAPSS) method to detect and count red blood cells (RBC), nucleated red blood cells (NRBC), platelets (PLT), and white blood cells (WBC), and to perform WBC differentials (DIFF) in whole blood. There is also an option to choose whether to detect reticulocytes (RETIC) at the same time. The options of the selections are: - CBC+DIFF: Complete blood count with differential - CBC+DIFF+RETIC: Complete blood count with differential and reticulocyte ● The Alinity h-series of instruments has a scalable design to provide full integration of multiple automated hematology analyzers that can include the integration of an automated blood film preparation and staining module, all of which are controlled by one user interface. The modules are designed to fit together. Each module has an internal conveyor that enables racks of specimen tubes to be transported between modules. The system can move racks between modules to perform different tests on a given specimen (e.g., make slide smears on the Alinity hs). An Alinity h-series system can be configured as follows: - Configuration 1: 1 (Alinity hq) + 0 (Alinity hs) = 1+0 - . Configuration 2: 1 (Alinity hq) + 1 (Alinity hs) = 1+1 - . Configuration 3: 2 (Alinity hq) + 0 (Alinity hs) = 2+0 - . Configuration 4: 2 (Alinity hq) + 1 (Alinity hs) = 2+1

The Cito CBC system is a quantitative automated hematology analyzer intended for in-vitro diagnostic use to determine the following parameters with whole blood anticoagulated with K2EDTA (Venous): - CBC parameters: white blood cell count (WBC), red blood cell count (RBC), platelet count (PLT), hemoglobin concentration (HGB), hematocrit (HCT), and mean corpuscular volume (MCV); - 5-Part WBC Differential (WBC Diff): neutrophil count and percentage (NEUT and NEUT%), lymphocyte count and percentage (LYMPH and LYMPH%), monocyte count and percentage (MONO and MONO%), eosinophil count and percentage (EO and EO%), basophil count and percentage (BASO and BASO%). It is not indicated for use in diagnosing or monitoring of oncology patients, critically ill patients, or children under the age of 2 years.

The Cito CBC system is an automated hematology analyzer that is intended to analyze human whole blood, and report results of 16 hematology parameters. The system consists of a tabletop analyzer, the Cito CBC Analyzer, and a disposable test cartridge, the Cito CBC Cartridge. The analyzer includes software with Graphic User Interface to guide users to complete test procedure. To perform a test, the test cartridges and other test consumables are provided as a test kit. The current version of the test cartridge is designed for testing whole blood anticoagulated with K2EDTA. The current version of the test kit is designed for testing venous whole blood collected in a vacutainer tube. The Cito CBC analyzer utilizes the principle of fluorescent flow cytometry for cell count and cell classification. A laser is used as the light source, and fluorescence and light scattering signals are detected for the measurements. For fluorescent labeling, blood cells are treated with a fluorescent dye that has high affinity binding to nucleic acid. Additionally, the analyzer utilizes the principle of two-wavelength photometry for the measurement of hemoglobin. Blood cells are lysed to release hemoglobin. Meanwhile, the light scattering signal measured from the flow cytometry and the light absorption signals measured from the photometry are both used to quantify the hematocrit and the mean corpuscular volume. The Cito CBC cartridge is self-contained with all reagents to perform a test. The blood sample is applied to the test cartridge, and the test cartridge is inserted into the analyzer to complete the test. The analyzer has a pneumatic module which provides pressure to the cartridge and drives the applied sample to mix with reagents to form multiple sample mixtures. The cartridge has transparent flow cells to support the measurements of sample mixtures by fluorescent flow cytometry and photometry. The sample mixtures and the measurement wastes are all self-contained inside the cartridge for safe disposal after the test.

The UniCel DxH 900/DxH 690T Coulter Cellular Analysis System is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 900/DxH 690T analyzer identifies and enumerates the following parameters: · Whole Blood (Venous or Capillary): WBC, RBC, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO%, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF · Pre-Diluted Whole Blood (Venous or Capillary): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV · Body Fluids (cerebrospinal, serous or synovial): TNC and RBC The UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

The UniCel DxH 900/DxH 690T System contains an automated hematology analyzer (DxH 900 or DxH 690T) designed for in vitro diagnostic use in screening patient populations by clinical laboratories. The system provides a Complete Blood Count (CBC), Leukocyte 5-Part Differential (Diff), Reticulocyte (Retic), Nucleated Red Blood Cell (NRBC) on whole blood, as well as, Total Nucleated Count (TNC), and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial). The DxH Slidemaker Stainer II is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. The DxH 900 System may consist of a workcell (multiple connected DxH 900 instruments with or without a DxH Slidemaker Stainer II), a stand-alone DxH 900, or a stand-alone DxH Slidemaker Stainer II. The DxH 690T System consists of a stand-alone DxH 690T instrument.

The Yumizen H2500 is a quantitative multiparameter fully automated hematology analyzer intended for in-vitro diagnostic use in clinical laboratories by qualified healthcare professionals for the screening of patient populations. The Yumizen H2500 is intended to perform tests on the following specimens: - Anticoagulated whole blood specimens ● - Body fluids (synovial fluids, serous fluids and cerebrospinal fluids). . The Yumizen H2500 classifies and enumerates the following parameters: - A complete blood count (CBC) consisting of TNC, WBC, RBC, HGB, calculated . HCT, MCV, calculated MCH, calculated MCHC, RDW-SD, RDW-CV, PLT, PLT-Ox, LPF, MPV. - A leukocyte differential count consisting of LYM (%#), MON (%#), NEU (%/#), ● EOS (%/#), BAS (%/#), IMG (%/#) - A nucleated red blood cell count consisting of NRBC (%/#). ● - A reticulocyte analysis consisting of RET (%/#), calculated CRC, IRF, RHCC. ● - Quantitative determination of blood cells in synovial fluids, serous fluids and . cerebrospinal fluids consisting of BFWBC, BFRBC, BFPN (%/#), BFMN (%/#). Note: Venous and capillary whole blood should be collected in K2EDTA anticoagulant. Serous and synovial fluids should be collected without anticoagulant or in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with cerebrospinal fluid specimens is neither required nor recommended. Alternatively, Sodium Heparin or Lithium Heparin may be used for synovial fluid.

The HORIBA Medical analyzer modules Yumizen H2500 are multi-parameter hematology analyzers intended to perform tests on whole blood samples collected in K2EDTA and body fluids (synovial and serous) collected in K2EDTA anticoaqulant. The analyzers can also perform tests on cerebrospinal fluids which should not be collected in any anticoaqulant. The Analyzer Units (Yumizen H2500) aspirate, dilute, mix, and analyze blood and body fluid samples. The Yumizen H2500 model provides Complete Blood Count (CBC), Differential (DIFF), Reticulocyte counts (RET) and Optical Platelet counts as well as Body Fluid counts (BF). The analyzer models may function with: - · a Data Management Unit (Yumizen P8000) which is the interface with the laboratory connections (LIS) and the Analyzer Unit(s). Through its interface, the Yumizen P8000 enables the user to monitor the workflow of patient data, centralize result data, perform reflex testing, customize rules, centralize the validation operations, run quality control, manage quality assurance on results.

The HemoScreen is a point-of-care (POC) automated hematology analyzer intended for the enumeration and classification of the following parameters in capillary and venous whole blood (K2EDTA anticoagulated): WBC, RBC, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, NEUT%, NEUT#, LYMP%, LYMP#, MONO%, MONO#, EO%, EO#, BASO%, and BASO#. The HemoScreen is for in vitro diagnostic use in clinical laboratories and/or POC settings for adults and children at least 2 years of age.

HemoScreen is a point of care (POC), automated hematology analyzer that provides 20 common CBC parameters, including a 5-part leukocyte (WBC) differential, in capillary and venous whole blood samples. The HemoScreen analyzer (reader) is a tabletop device that is designed to use with a disposable reagent Cartridge. In addition to the Cartridge, the system includes a disposable Sampler with two glass capillaries which is used to collect the blood sample and then transfer it to the Cartridge. Once the Cartridge is inserted into the reader, there are no further procedural steps; blood is expelled from the capillaries (Sampler) into the reagent compartments (Cartridge). The reader then mixes the blood sample with the reagents by alternately pressing compressible portions of the Cartridge, eventually causing the suspension of cells to flow into the microfluidic chamber. Cells flowing in the microfluidic chamber focus into a single-cell plane due to a patented physical phenomenon known as viscoelastic focusing. The reader then captures images of the focused cells and analyzes them in real time using machine vision algorithms. When analysis is complete, the results are displayed to the user on the reader's touch screen and may be printed to an adjacent printer or exported to a USB flash drive. The Cartridge is ejected by the analyzer after analysis, and can then be safely disposed of, as the reagents and blood sample remain within the Cartridge. The basic staining and microscopic image analysis performed by HemoScreen closely resembles the traditional blood smear and the hemocytometer counting chamber. Leukocytes are classified based on their staining properties and morphology, whereas absolute counts are obtained by counting the cells contained in a chamber of predetermined volume. Test results are obtained within less than six (6) minutes and the results are saved. Quality Control: Commercial 3-level liquid quality controls, PIX-CBC Hematology Controls, are recommended for use with the HemoScreen. These controls cover all the tested parameters and are sampled the same way whole blood is sampled. Software: The HemoScreen software displays an intuitive, simple-to-use user interface that is operated via the touch screen. The software is responsible for operating the device, performing the measurements, and recording the results.

The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#.

The Sysmex XQ-Series (XQ-320) automated hematology analyzer is a multi-parameter hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates whole blood parameters by DC (Direct Current) detection method and non-cyanide HGB analysis method (Colorimetric method) on whole blood samples collected in K2 or K3EDTA anticoagulant. The XQ-320 analyzer consists of one unit which aspirates and dispenses diluent to prepare blood dilutions and analyzes whole blood samples. The operator must mix the sample manually then introduce the sample tube to the aspiration pipette with the cap off, and presses the start switch to execute aspiration and analysis. The XQ-320 analyzer uses a built-in monitor to operate the analyzer and process data.

The OScout™ Lab is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. The QScout Lab is used with the QScout RLD test to enumerate and classify the following parameters in venous K2/K3EDT A whole blood: - White blood cell count (WBC) - · Neutrophils (NEUT#) - · Lymphocytes (LYMPH#) - · Monocytes (MONO#) - · Eosinophils (EOS#) - · Basophils (BASO#) - · Immature Granulocytes (IG#) - · Percent Neutrophils (NEUT%) - Percent Lymphocytes (LYMPH%) - · Percent Monocytes (MONO%) - · Percent Eosinophils (EOS%) - · Percent Basophils (BASO%) - · Percent Immature Granulocytes (IG%) - · Neutrophil to Lymphocyte Ratio (NLR)

The QScout™ system is intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. It includes the QScout Lab analyzer, the QScout RLD (Rapid Leukocyte Differential) test, software, and handheld barcode scanner. The QScout system reports white blood cell count and neutrophil to lymphocyte ratio and enumerates and classifies six white blood cell types including immature granulocytes. The QScout RLD test includes a microfluidic chamber of predetermined volume containing a dried reagent of organic compounds to stain and fluoresce white blood cells. Once venous whole blood is transferred to the QScout RLD test, white blood cells mix with the reagent. The QScout RLD test is inserted into the QScout Lab, a quantitative multi-parameter automated hematology analyzer, where an optical imaging system takes images of the test chamber. A machine vision algorithm identifies cells from the images in real time. When analysis is complete, the results are displayed on the screen and can be printed.

The HemoScreen is a point-of-care (POC) automated hematology analyzer intended for the enumeration and classification of the following parameters in capillary and venous whole blood (K2EDTA anticoagulated): WBC, RBC, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, NEUT%, NEUT#, LYMP%, LYMP#, MONO%, MONO#, EO%, EO#, BASO%, and BASO#. The HemoScreen is for in vitro diagnostic use in clinical laboratories and/or POC settings for adults and children at least 2 years of age.

HemoScreen is a point of care (POC), automated hematology analyzer that provides 20 common CBC parameters, including a 5-part leukocyte (WBC) differential, in capillary and venous whole blood samples. The HemoScreen analyzer (reader) is a tabletop device that is designed to use with a disposable reagent Cartridge. In addition to the Cartridge, the system includes a disposable Sampler with two glass capillaries which is used to collect the blood sample and then transfer it to the Cartridge. Once the Cartridge is inserted into the reader, there are no further procedural steps; blood is expelled from the capillaries (Sampler) into the reagent compartments (Cartridge). The reader then mixes the blood sample with the reagents by alternately pressing compressible portions of the Cartridge, eventually causing the suspension of cells to flow into the microfluidic chamber. Cells flowing in the microfluidic chamber focus into a single-cell plane due to a patented physical phenomenon known as viscoelastic focusing. The reader then captures images of the focused cells and analyzes them in real time using machine vision algorithms. When analysis is complete, the results are displayed to the user on the reader's touch screen and may be printed to an adjacent printer or exported to a USB flash drive. The Cartridge is ejected by the analyzer after analysis, and can then be safely disposed of, as the reagents and blood sample remain within the Cartridge. The basic staining and microscopic image analysis performed by HemoScreen closely resembles the traditional blood smear and the hemocytometer counting chamber. Leukocytes are classified based on their staining properties and morphology, whereas absolute counts are obtained by counting the cells contained in a chamber of predetermined volume. Test results are obtained within six (6) minutes and the results are saved. Quality Control: Commercial 3-level liquid quality controls, PIX-CBC Hematology Controls, are recommended for use with the HemoScreen. These controls cover all the tested parameters and are sampled the same way whole blood is sampled. Software: The HemoScreen software displays an intuitive, simple-to-use user interface that is operated via the touch screen. The software is responsible for operating the device, performing the measurements, and recording the results.