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The HemoPoint® H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood. The HemoPoint H2 Microcuvettes are indicated for use in the HemoPoint® H2 DM Hemoglobin Measurement System. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste. Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter ). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported. The DM (Data Management) system allows enhanced data management features. For In Vitro Diagnostic Use Only

The HemoPoint® H2 Hemoglobin Measurement System is comprised of a HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes. A modified azide methemoglobin method is used in the HemoPoint® H2 system. In the HemoPoint® H2, however, the use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled cuvette is inserted into the HemoPoint® H2 photometer, the color produced by the chemical reaction in the cuvette is measured, and the Hb level is calculated and displayed. In the HemoPoint® H2 photometer the light transmitted through the cuvette sample is measured. For this purpose, light is directed through the blood sample and the transmission T is measured. From the amount of light absorbed by the sample, the concentration of the hemoglobin in the cuvette can be calculated using Lambert-Beers Law. Light emitting diodes (LED's) are used as light sources and a photodiode to detect the light. The light emitting diodes utilize the central wavelengths 570 nm (for measurement) and 880 nm (for turbidity compensation). The DM (Data Management) software modification allows the storage and retrieval of data results along with patient information.

The HemoPoint® H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood. The microcuvettes part number 3010-100 are indicated for use in the HemoPoint® H2 Hemoglobin Measurement System and the Hemocue® measurement system. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste. Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter ). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported. For In Vitro Diagnostic Use Only

The HemoPoint® H2 Hemoglobin Measurement System is comprised of a HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes. A modified azide methemoglobin method is used in the HemoPoint® H2 system. In the HemoPoint® H2, the use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled cuvette is inserted into the HemoPoint® H2 photometer, the color produced by the chemical reaction in the cuvette is measured, and the Hb level is calculated and displayed. In the HemoPoint® H2 photometer the light transmitted through the cuvette sample is measured. Light emitting diodes (LED's) are used as light sources and a photodiode to detect the light. The light emitting diodes utilize the central wavelengths 570 nm (for measurement) and 880 nm (for turbidity compensation).

The Stanbio Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® test systems are devices intended to measure the levels of bilirubin (direct and total) in serum and plasma. Measurements of the levels of bilirubin, and organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

The Direct Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. The Total Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2.

The Stanbio Creatinine LiquiColor® test system is a device intended to measure creatinine levels in serum or urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

The Creatinine LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. To calibrate the test kit, a calibrator is used that has values determined by a similar method.

The Sirrus® Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes to include Glucose, Cholesterol, and Triglycerides.

The Sirrus® Clinical Chemistry Analyzer is an automated system for quantitative analysis of clinical chemistries. The analyzer is intended for clinical use in conjunction with certain materials to measure a variety of analytes.

Direct LDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in serum or plasma. LDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders. For In Vitro Diagnostic Use Only.

The device is a system using the reagent and calibrator in combination to directly measure the LDL-Cholesterol. This is achieved by a homogenous method that directly measures serum LDL-Cholesterol levels without the need for any off-line pretreatment or centrifugation steps. It employs a two-reagent system. The first reagent (R1) contains a combination of detergent, organic and inorganic phosphoric acid compounds, which specifically binds HDL, VLDL and chylomicrons leaving the LDL particles exposed. The second reagent (R2) contains enzymes, which then react with the LDLcholesterol present in the sample.

Direct HDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum or plasma. HDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.

The device is a system using the reagent and calibrator in combination to directly measure the HDL-Cholesterol. This is achieved by a homogenous method that directly measures serum HDL Cholesterol levels without the need for any off-line pretreatment or centrifugation steps. It employs a two-reagent system. The first reagent (R1) contains a combination of detergent, organic and inorganic phosphoric acid compounds, which specifically binds LDL, VLDL and chylomicrons leaving the HDL particles exposed. The second reagent (R2) contains enzymes, which then react with the HDLcholesterol present in the sample.

The HemoPoint® H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood. The microcuvettes part number 3010-100 are indicated for use in the HemoPoint® H2 Hemoglobin Measurement System and the Hemocue® measurement system. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste. Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter ). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported. For In Vitro Diagnostic Use Only

The HemoPoint® H2 Hemoglobin Measurement System is comprised of a HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes. A modified azide methemoqlobin method is used in the HemoPoint® H2 system. In the HemoPoint® H2, the use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled cuvette is inserted into the HemoPoint® H2 photometer, the color produced by the chemical reaction in the cuvette is measured, and the Hb level is calculated and displayed. In the HemoPoint® H2 photometer the light transmitted through the cuvette sample is measured. Light emitting diodes (LED's) are used as light sources and a photodiode to detect the light. The light emitting diodes utilize the central wavelengths 570 nm (for measurement) and 880 nm (for turbidity compensation).

QuPID® Plus E.R. pregnancy device is intended for qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy.

The test is comprised of colored dye coated with polyclonal antibodies specific for hCG, immobilized antibodies against hCG and monoclonal anti-mouse lgG antibodies. The assay is conducted by adding specimen, urine or serum, to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody hCG colored conjugate and form a colored line in the Specimen Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.