Sysmex America, Inc.

Address: One Nelson C. White Parkway, Mundelein, Illinois 60060, USA
Phone: +1-(847)-996-4500, 800-379-7639 | Fax: +1-(847)-996-4559 | Map/Directions >>

Profile: Sysmex America, Inc. manufactures and markets clinical laboratory testing devices, reagents, and software for hematology, hemostasis, immuno-chemistry, particle counting and urinalysis and also distributes in vitro reagents specifically for use in Sysmex's hematology, coagulation, and urinalysis analyzers. Our CellaVision™ DM96 is an automated digital cell morphology & informatics system for the location, pre-classification/characterization, display, storage & transmission of white & red blood cells images.

FDA Registration Number: 1422681

31 Products/Services (Click for related suppliers)  
• Automated Cell Counter (FDA Code: GKL / 864.5200)
An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.
• Automated Coagulation Analyzer (FDA Code: GKP / 864.5400)
A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.
• Automated Coagulation Instrument (FDA Code: GKP / 864.5400)
• Automated Digital Cell Morphology System
• Automated Hematology Analyzers
• Blender/Mixer (FDA Code: JRO / 862.2050)
General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
• Blood Cell Diluent (FDA Code: GIF / 864.8200)
A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
• Blood Clot Coagulation Analyzer (FDA Code: GKP / 864.5400)
• Blood, Hematology Analyzers
• Coagulation Analyzer with Timer (FDA Code: GKP / 864.5400)
• Coagulation Analyzers (FDA Code: GKP / 864.5400)
• Controls
• Data Processing Module for Clinical use (FDA Code: JQP / 862.2100)
A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data.
• Differential Cell Counter (FDA Code: GKZ / 864.5220)
An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.
• Flow Particle Image Analyzer
• General Diagnostic Supplies
• General Diagnostics
• General Purpose Reagent (FDA Code: LDT / 864.4010)
• Hematology Analyzers
• Laboratory Hematology Analyzers
• Multichannel Hematology Analyzers
• Particle and Cell Urinalysis Systems
• Pregnancy Kits
• Red Cell Lysing Fluid (FDA Code: GGK / 864.8540)
A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.
• Refurbished Hematology Analyzers
• Smaller Hematology Analyzers
• Specialty Diagnostic Supplies
• Surrogate Calibrator (FDA Code: JIW / 862.1150)
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.)
• Urinalysis Controls (FDA Code: JJW / 862.1660)
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
• Urine Particle Counter (FDA Code: LKM / 864.5200)
• Wright's Stain (FDA Code: IAF / 864.1850)
Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

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