HemoCue AB

Click Here To EMAIL INQUIRY
Contact: Olle Hagstrom - Market Development Manager
Web: http://www.hemocue.se
E-Mail:
Address: Box 1204, Angelholm 26223, Sweden
Phone: +46-(77)-5700210 | Fax: +46-(77)-5700212 | Map/Directions >>

Profile: HemoCue AB develops, produces and markets medical diagnostic products. Our products are applied to perform blood and urine tests. Our product range includes HemoCue glucose systems, plasma/low Hb system, hemoglobin systems, albumin systems and 201 DM systems. Our glucose systems are based on a glucose dehydrogenase method and consist of a small dedicated analyzer & disposable microcuvette. The systems combine the precision and accuracy of a central laboratory with the speed and convenience of obtaining results at the point-of-care. Our system produces immediate & accurate results for screening, diagnosing or monitoring diabetes and monitoring neonatal blood glucose levels. Our albumin systems can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening, diagnosing, monitoring and supporting the clinical evidence in the treatment of microalbuminuria. The system consists of an analyzer and individually packaged microcuvettes. The reaction in the cuvette is based on a immunoturbidimetric reaction. The turbidity once formed is measured photometrically at 610 nm.

The company has revenues of USD 1-5 Million, has ~150 employees.

FDA Registration Number: 3003044483
US Agent: Matt Ackerman / Radiometer America Inc.
Phone: +1-(657)-286-1022 E-Mail:

12 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 Hemoglobin System (FDA Code: GKR / 864.5620)

An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.

• Automated Urinalysis System (FDA Code: KQO / 862.2900)

An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

• Discrete Photometric Chemistry Analyzer (FDA Code: JJE / 862.2160)

A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

• Glucose Analyzers

• Glucose Glucose Dehydrogenase (FDA Code: LFR / 862.1345)

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

• Glucose Oxidase, Glucose (FDA Code: CGA / 862.1345)

• Hemoglobin and Hematocrit Measurement Calibrator (FDA Code: KRZ / 864.8165)

A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.

• Hemoglobin Control (FDA Code: GGM / 864.8625)

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

• Protein /Albumin Turbidimetric Method (FDA Code: JIQ / 862.1645)

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

• Thermostated Cuvette (FDA Code: JRI / 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.

• Whole Blood Hemoglobin Determination Test (FDA Code: KHG / 864.7500)

A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.