Lre Medical Gmbh
Profile: Lre Medical Gmbh offers assayed and unassayed single analyte controls, fluorometer for clinical use, automated hemoglobin systems and urinary enzymatic methods.
FDA Registration Number: 3003366417
US Agent: Robert A. Giroux / Advanced Input
Phone: +1-(1)-635-8213 E-Mail:
26 Products/Services (Click for related suppliers)
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| • 4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA / 862.1095) An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, serum, and urine. Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary deficiencies. |
| • Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 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. |
| • 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. |
| • Bilirubin and Conjugates Colorimetric Azo-Dyes Test (FDA Code: JJB / 862.1115) A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases. |
| • Copper Sulfate Solution (FDA Code: KSL / 864.9320) A copper sulfate solution for specific gravity determinations is a device used to determine whether the hemoglobin content of a potential donor's blood meets the required level (12.5 grams per 100 milliliters of blood for women and 13.5 grams per 100 milliliters of blood for men). |
| • 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. |
| • Enzymatic Esterase-Oxidase, Cholesterol (FDA Code: CHH / 862.1175) A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. |
| • Fluorometer for Clinical Use (FDA Code: KHO / 862.2560) A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain materials to measure a variety of analytes. |
| • 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) |
| • Infusion Pump Accessories (FDA Code: MRZ / 880.5725) An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm. |
| • Insulin Infusion Pump (FDA Code: LZG / 880.5725) |
| • Isoenzymes Fluorometric Method (FDA Code: JHX / 862.1215) A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. |
| • Myoglobin (FDA Code: DDR / 866.5680) A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease. |
| • Non-Quantitative Urobilinogen Test (FDA Code: CDM / 862.1785) A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders. |
| • Over-The-Counter Blood Glucose Test System (FDA Code: NBW / 862.1345) |
| • Troponin Subunit Enzymatic Method (FDA Code: MMI / 862.1215) |
| • Urinary Enzymatic Method (FDA Code: JIL / 862.1340) A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. |
| • Urinary Ketones, Nitroprusside Test (FDA Code: JIN / 862.1435) A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes. |
| • Urinary Nitrite Colorimetric Test (FDA Code: JMT / 862.1510) A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin. |
| • Urinary Occult Blood Enzymatic Method (FDA Code: JIP / 864.6550) An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.) |
| • Urinary pH Dye Indicator (FDA Code: CEN / 862.1550) A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets. |
| • Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR / 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. |
| • Urine Leukocyte Test (FDA Code: LJX / 864.7675) A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias. |
| • 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. |
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