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The HemoCue® Hb 301 System is intended for quantitative determination of hemoglobin in primary care or blood donation settings. The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old in primary care setting. The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults in blood donation setting. The HemoCue® Hb 301 System is for professional in vitro diagnostic use only.

The HemoCue® Hb 301 System provides a direct reading of the hemoglobin concentration in a sample using specially designed, single use microcuvette and an analyzer. The system can be used by non-laboratory personnel. The HemoCue® Hb 301 System consists of the following parts: - An analyzer supporting the following features: - Photometric determination of hemoglobin - Presentation of results on a display - Power supply by power adapter or four AA batteries - Single use microcuvettes (test consumable) - Labeling: - Operating Manual - Package Insert - Quick reference Guide - Labels The microcuvette serves both as a pipette and as a measuring cuvette. No dilution or other preparation of the blood sample is required before filling of the microcuvette. A whole blood sample of approximately 10 µL is drawn into the cavity in the microcuvette by capillary action. The measurement takes place in the analyzer, which measures the absorbance of whole blood at an Hb/ HbO2 isosbestic point. The measurement is performed directly on the whole blood through measurement of the transmitted and scattered light and using an algorithm for translation into the hemoglobin concentration of the sample. The HemoCue® Hb 301 System is traceable to the hemiglobincyanide (HiCN) method, the international reference method according to ICSH for the determination of the hemoglobin concentration in blood.

The HemoCue® Hb 801 System is intended for the quantitative determination of hemoglobin in capillary or venous whole blood (K2EDTA and Li-Heparin) in point-of-care settings. The HemoCue® Hb 801 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old. The HemoCue® Hb 801 System is for professional in vitro diagnostic use only.

The HemoCue® Hb 801 System provides a direct reading of the hemoglobin concentration in a sample using specially designed, single use microcuvette and an analyzer. The system can be used by non-laboratory personnel. The HemoCue® Hb 801 System consists of the following parts: - An analyzer supporting the following features: . - O Photometric determination of hemoglobin - Presentation of results on a display O - O Wired and wireless communication (USB and Bluetooth) - Power supply by power adapter, chargeable or non- chargeable batteries ● - Single use microcuvettes (test consumable) - Labeling: ● - O Operating Manual - o Package Insert - Quick reference Guide o - o Labels The microcuvette serves both as a pipette and as a measuring cuvette. No dilution or other preparation of the blood sample is required before filling of the microcuvette. A whole blood sample of approximately 10 uL is drawn into the cavity in the microcuvette by capillary action. The measurement takes place in the analyzer, which measures the absorbance of whole blood at an Hb/ HbO2 isosbestic point. The measurement is performed directly on the whole blood through measurement of the transmitted and scattered light and using an algorithm for translation into the hemoglobin concentration of the sample. The HemoCue® Hb 801 System is traceable to the hemiglobincyanide (HiCN) method, the international reference method according to ICSH for the determination of the hemoglobin concentration in blood.

The HemoCue WBC system is indicated for use for quantitative determination of white blood cell (WBC) count in capillary or venous whole blood. The HemoCue WBC system is for In Vitro Diagnostic use only. The HemoCue WBC Analyzer is only to be used with HemoCue WBC Microcuvettes. The HemoCue WBC system is indicated for use in clinical laboratories and for point-of-care settings.

The system consists of the HemoCue WBC Analyzer together with specially designed microcuvettes, the HemoCue WBC Microcuvettes. The microcuvette serves both as a sample container and a reaction chamber. A blood sample of approximately 10 uL is drawn into the cavity by capillary action. A hemolysing agent lyses the red cells in the microcuvette and a staining agent colors the white blood cells. An image is taken of the stained white blood cells and the number of cells is counted by image analysis. The result is presented within 3 minutes on the analyzer's display. The system reports results in the measuring range 0.3 - 30.0 x107/L. The system is factory calibrated and needs no further calibration. The HemoCue WBC Analyzer is a portable device. The main parts are the cuvette holder (in which the microcuvette is placed), the cuvette moving arm (brings the microcuvette into correct measuring position), a magnifying optic unit, a camera, image processing software, a display and a power adapter. The HemoCue WBC Microcuvette is made of polystyrene plastic and contains saponin that hemolyzes the red blood cells, methylene blue that stains the white blood cells and nonactive reagents. A blood sample of approximately 10 µL is drawn into the cavity by capillary action. The microcuvette serves as a sample container and a reaction chamber. No dilution of the sample is required.

The HemoCue Glucose 201 RT system is used for quantitative determination of glucose in whole blood supplementing the clinical evidence in the diagnosis and treatment of patients with diabetes. The HemoCue Glucose 201 RT system is for In Vitro Diagnostic use only. The HemoCue Glucose 201 RT Analyzer is only to be used with HemoCue Glucose 201 RT Microcuvettes. For professional use only.

The HemoCue Glucose 201 RT system consists of a small and portable analyzer (photometer) and plastic microcuvettes. The HemoCue Glucose 201 RT Microcuvette contains reagents deposited on its inner walls and serves both as a pipette and as a measuring cuvette. A blood sample of approximately 4 uL is drawn into the cavity by capillary action. The filled microcuvette is inserted into the HemoCue Glucose 201 RT Analyzer. The measurement takes place in the analyzer in which the transmittance is measured and the absorbance and glucose level is calculated.

The HemoCue Hb 301 system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 301 Analyzer, and specially designed microcuvettes, the HemoCue Hb 301 Microcuvettes. The HemoCue Hb 301 system is for In Vitro Diagnostic use only. The HemoCue Hb 301 Analyzer is only to be used with HemoCue Hb 301 Microcuvettes.

The HemoCue Hb 301 system consists of a small and portable analyzer (photometer) and plastic microcuvettes. The microcuvette serves both as a pipette and as a measuring cuvette. A blood sample is drawn into the cavity by capillary action. The filled microcuvette is inserted into the HemoCue Hb 301 Analyzer. The measurement takes place in the analyzer, which measures the absorbance of whole blood at a Hb/HbO.isobestic point. The system is factory calibrated and needs no further calibration.

The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed system, the HemoCue Albumin 201 analyzer. The system is designed to be used for the quantitative determination of low levels of albumin in urine at the point-of-care for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes. For professional use only.

The HemoCue Albumin 201 analyzing system consists of an analyzer and specially designed microcuvettes. The microcuvette contains reagents deposited on its inner walls. The plastic microcuvette is filled with a urine sample and inserted into the analyzer. Within the analyzer, the contents of the cuvette are mixed through vibration. The immunochemical reaction is completed and the turbidity is measured. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L.