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The Sysmex UF-50 is a fully automated urine cell analyzer intended for in vitro diagnostic use in urinalysis within the clinical laboratory. The UF-50 replaces microscopic review of normal/abnormal specimens and flags specimens containing certain abnormalities which indicate the need for further testing. Laboratorians are responsible for final microscopic review of flagged abnormalities.

The UF-50 is a fully automated urine cell analyzer for urinalysis in clinical laboratories. It analyzes formed elements in urine using flow cytometry technology.

The Sysmex™ XE-2100 is a multi-parameter hematology analyzer intended to classify the following formed elements in anti-coagulated blood: WBC, Neut%/#, Lymph%/#, Mono%/#, Eo%/#, Baso%/#, NRBC%/#, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, RET%/#, IRF, HFR*, MFR*, LFR*, PLT, MPV, PDW*, P-LCR*, PCT* (*Not Reportable in USA).

The XE-2100 is an automated hematology analyzer which consists of four principal units: (1) Main Unit which aspirates, dilutes, mixes, and analyzes whole blood samples; (2) Sampler Unit which supplies 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 intended use of the Sysmex R-3500 is as a fully automated reticulocyte analyzer for in vitro diagnostic use in clinical laboratories.

The Sysmex™ R-3500 is an automated reticulocyte analyzer intended for in vitro use in clinical laboratories. The R-3500 provides accurate and precise test results for 8 analysis parameters in whole blood. These include RET%, RET#, RBC, IRF, LFR, MFR, HFR, and PLT. The R-3500 processes approximately 120 samples per hour and displays and prints the data for Reticulocyte number, Reticulocyte percent, Red blood cell count, Immature reticulocyte fraction, fluorescent ratios, and platelets along with representative scattergrams. Sample abnormalities are indicated by abnormal marks, flags, and error messages which appear on the DMS display screen and on the printout. This is an indication that the sample is not within the acceptable range and requires further review and investigation. The R-3500 uses the principle of flow cytometry for reticulocyte analysis. In the instrument, a whole blood sample is automatically aspirated, diluted and stained with a fluorescent dye (Auromine-O). The sample is hydrodynamically focused into a narrow path and passed through a flow cell, where it is illuminated by an Argon laser beam. The cells present in the sample will fluoresce and scatter light to varying degrees. It is the analysis of the intensity of emitted fluorescent light and intensity of scattered light which allows the R-3500 analyzer to detect and enumerate reticulocytes.

The intended use of the Sysmex KX-21 is as an automated cell counter for in vitro diagnostic use in clinical laboratories.

The Sysmex™ KX-21 is an automated blood cell counter intended for in vitro diagnostic use in clinical laboratories.

The IRF parameter of the R-Series analyzers is intended for in-vit-vouse in --clinical laboratories. Its clinical use is to monitor bone marrow suppression and recovery in terms of erythropoiesis in situations of previous cancer chemotherapeutic bone marrow suppression and bone marrow transplantation. Qualified laboratory personnel are responsible for review of all abnormal results.

The R-1000, R-3000 and RAM-1 are table-top analyzer systems for automated reticulocyte counting. These instruments are dedicated flow cytometers which dilute and stain whole blood with a fluorescent dye (Auromine-O), then count and measure fluorescence and scatter of stained blood cells. The fluorescence intensity is measured, and the analyzer identifies the reticulocytes based on fluorescence and scatter. The fluorescent intensity of the reticulocytes is displayed on the analyzer as a scattergram, and this display is separated into three regions: Low Fluorescence Intensity (LFR), Middle Fluorescence Intensity (MFR), and High Fluorescence Intensity (HFR). These regions are reported as a ratio or percentage(sum = 100%), in addition to the analyzer's reporting total reticulocyte count and RBC count. The IRF parameter is determined by the sum of the MFR (Middle Fluorescence Ratio) and HFR (High Fluorescence Ratio) {MFR+HFR=IRF}.

Sysmex® CA-1000 & CA-5000 are intended for use as automated blood plasma coagulation analyzers.

Automated blood plasma coagulation analyzers. The systems were described in details in premarket notifications, document control numbers: K931149/A, K933886, K942096/S1 and K942097/S1. The devices belong to the same family of instruments and they are equivalent in their technological features and performance.

The SE/RAM-1 is an In Vitro device for whole blood cell analysis in clinical laboratories. The SE-9000 portion is intended for blood cell analysis; the RAM-1 portion is intended for automated reticulocyte analysis. The instrument is a screening device for identifying abnormal blood specimens. Medical technologists are responsible for final review of abnormal cells.

The SE/RAM-1 is a table-top analyzer system consisting of a blood cell counting unit (SE-9000), a reticulocyte unit (RAM-1), a Data Management System, and a printer. A Sampler Unit is attached to the SE-9000 unit, which transports samples in cassette racks to the ID bar code reader and then to the Automatic mixing/Cap piercing device. The SE/RAM-1 system has the capability of reporting up to 23 parameters. The 23 reportable parameters are as follows: RBC, Hgb, HCT, MCV, MCH, MCHC,RDW-CV, RDW-SD. PLT. MPV. WBC. NEUT%. LYMPH%. MONO%. EO%. BASO%, NEUT#, LYMPH#, MONO#, EO#, BASO# (all from SE-9000 unit), RETIC %, RETIC# (from RAM-1 unit). The SRV of the SE-9000 contains a port (in the original design of the instrument) by which the reticulocyte module(RAM-1) is attached. The SRV splits the blood sample into 8 aliquots. 7 aliquots are delivered to the SE-9000 system, diluted with the appropriate diluent or lyse and sent to their respective detector blocks for analysis. The 8th aliquot is sent to the RAM-1 where it is diluted and stained, then sent to the flow cell for analysis. The SE/RAM-1 system uses a total of up to 13 reagents. All reagents are the same as used on the stand-alone SE-9000 and the R-3000 analyzers.

UF-Check™ is intended for use in the quality control of Sysmex UF-100™ automated urine analyzer. The Sysmex UF-100 is a in vitro medical device for use in urinalysis in clinical laboratories to replace microscopic review of normal and abnormal specimens and to flag specimens containing certain abnormalities.

UF-Check is a suspension of particles representing red blood cells, white blood cells, epithelial cells, casts, and bacteria in a liquid medium. Sysmex UF-Check is supplied in glass bottles containing 47 ml volumes. Three bottles - one of each level- are packaged in one box.