Radiometer Medical Aps

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Contact: Jana Hellmann
Web: http://www.radiometer.com
E-Mail:
Address: Aakandevej 21, Broenshoej 2700, Denmark
Phone: +45-(38)-273-827 | Fax: +45-(38)-272-727 | Map/Directions >>

Profile: Radiometer Medical Aps specializes in advanced acute care testing solutions. We focus on blood gas analysis, immunoassay testing and transcutaneous monitoring. Our products include blood gas analyzers, sensors for adult and pediatric patients, sensors for neonates and AQT90 flex. Our blood gas analyzer features streamline workflow, reduce errors and improve turnaround time. Our sensors for adult and pediatric patients & sensors for neonates provide transcutaneous pO2 and pCO2 informations. Our AQT90 flex analyzer measures cardiac, coagulation, infection and pregnancy markers from a single sample. The Flexlink scans and links sampler, patient and operator IDs at the bedside, making data readily available to caregivers and eliminating the risk of incorrect patient identification.

FDA Registration Number: 3002807968
US Agent: Matt Ackerman / Radiometer America, Inc.
Phone: +1-(657)-286-1022 E-Mail:

26 Products/Services (Click for related suppliers)

• Arterial Blood Sampling Kit (FDA Code: CBT / 868.1100)

An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.

• Automated Hematocrit Instrument (FDA Code: GKF / 864.5600)

An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

• Bilirubin Diazo Colorimetry Test (FDA Code: CIG / 862.1110)

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

• Blood Gas and Ph Electrode Measurement (FDA Code: CHL / 862.1120)

A blood gases (PCO2, PO2) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

• Blood Gas Controls (FDA Code: JJS / 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.

• Calcium Ion Specific Electrode (FDA Code: JFP / 862.1145)

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

• Capillary Blood Collection Tubes (FDA Code: GIO / 864.6150)

A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action.

• Carbon-Monoxide Oxyhemoglobin/Carboxyhemoglobin Curve Test (FDA Code: JKS / 862.3220)

A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.

• Carboxyhemoglobin Assay (FDA Code: GHS / 864.7425)

A carboxyhemoglobin assay is a device used to determine the carboxyhemoglobin (the compound formed when hemoglobin is exposed to carbon monoxide) content of human blood as an aid in the diagnosis of carbon monoxide poisoning. This measurement may be made using methods such as spectroscopy, colorimetry, spectrophotometry, and gasometry.

• Chloride Ion Specific Electrode (FDA Code: CGZ / 862.1170)

A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

• Cutaneous Carbon-Dioxide Monitor (FDA Code: LKD / 868.2480)

A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.

• Cutaneous Oxygen Monitor for Infant (FDA Code: KLK / 868.2500)

A cutaneous oxygen (PcO2) monitor is a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) placed on the patient's skin that is intended to monitor relative changes in the cutaneous oxygen tension.

• 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.

• Ear Oximeter (FDA Code: DPZ / 870.2710)

An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.

• Fetal Hemoglobin Assay (FDA Code: KQI / 864.7455)

A fetal hemoglobin assay is a device that is used to determine the presence and distribution of fetal hemoglobin (hemoglobin F) in red cells or to measure the amount of fetal hemoglobin present. The assay may be used to detect fetal red cells in the maternal circulation or to detect the elevated levels of fetal hemoglobin exhibited in cases of hemoglobin abnormalities such as thalassemia (a hereditary hemolytic anemia characterized by a decreased synthesis of one or more types of hemoglobin polypeptide chains). The hemoglobin determination may be made by methods such as electrophoresis, alkali denaturation, column chromatography, or radial immunodiffusion.

• For Uses Other Than For Infant Not Under Gas Anesthesia Cutaneous Oxygen Monitor (FDA Code: LPP / 868.2500)

• Glucose Oxidase, Glucose (FDA Code: CGA / 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.

• Ion Electrode Based Enzymatic Creatinine (FDA Code: CGL / 862.1225)

A creatinine test system is a device intended to measure creatinine levels in plasma and 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.

• Lactic Acid Enzymatic Method (FDA Code: KHP / 862.1450)

A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

• Lipoproteins Radial Immunodiffusion Test (FDA Code: JHP / 862.1475)

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

• Neonatal Total Bilirubin Test System (FDA Code: MQM / 862.1113)

A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

• Oximeters (FDA Code: DQA / 870.2700)

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

• Potassium Ion Specific Electrode (FDA Code: CEM / 862.1600)

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

• Sodium Ion Specific Electrode (FDA Code: JGS / 862.1665)

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

• Specified Concentration Calibration Gas (FDA Code: BXK / 868.6400)

A calibration gas is a device consisting of a container of gas of known concentration intended to calibrate medical gas concentration measurement devices.

• Whole Blood Oximeter (FDA Code: GLY / 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.