Profile: Siemens Healthcare Diagnostics, a clinical diagnostics company, provides clinicians with the vital information they need for the accurate diagnosis, treatment and monitoring of patients. Our comprehensive portfolio of performance-driven systems, unmatched menu offering and IT solution is designed to streamline workflow, enhance operational efficiency and support improved patient care.
The company is ISO 9000, CE certified. NASDAQ:DADE (SEC Filings)
• Urinalysis Controls (FDA Code: JJW / 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. |
• Urinalysis Test Stick |
• Urinalysis Work Cell |
• 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 Ferric Chloride Test (FDA Code: JGK / 862.1560) A urinary phenylketones (nonquantitative) test system is a device intended to identify phenylketones (such as phenylpyruvic acid) in urine. The identification of urinary phenylketones is used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation. |
• Urinary Glucose Non Quantitative Test System (FDA Code: JIM / 862.1340) |
• Urinary Homocystine Test System (FDA Code: LPS / 862.1377) A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation. |
• 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 Methylmalonic Acid Test System (FDA Code: LPT / 862.1509) A methylmalonic acid (nonquantitative) test system is a device intended to identify methylmalonic acid in urine. The identification of methylmalonic acid in urine is used in the diagnosis and treatment of methylmalonic aciduria, a heritable metabolic disorder which, if untreated, may cause mental retardation. |
• 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. |
• Valproic Acid Enzyme Immunoassay Test (FDA Code: LEG / 862.3645) A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs. |
• Vancomycin Radioimmunoassay (FDA Code: LEH / 862.3950) A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy. |
• Vantage Analyzer |
• Venous Blood Collection Tubes |
• Visible Spectrophotometers |
• Vitamin B12 Radioimmunoassay (FDA Code: CDD / 862.1810) A vitamin B12test system is a device intended to measure vitamin B12in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. |
• White Cell Diluting Fluid (FDA Code: GGJ / 864.8200) A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting. |
• 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. |
• Wooden Test Tube Rack |
• Wright's Stain (FDA Code: IAF / 864.1850) Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology. |
• Yeast Identification Kit (FDA Code: JXB / 866.2660) A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease. |
• Yeast Screening Kit (FDA Code: JXC / 866.2660) |
• Yellow Stopper Blood Collection Tube |