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)

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• Control Thromboplastin Reagent (FDA Code: GGO / 864.7925) A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

• Coombs Control

• Cortisol Fluorometric Test (FDA Code: JFT / 862.1205) A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

• Cortisol Radioimmunoassay Test (FDA Code: CGR / 862.1205)

• CPK Isoenzymes Catalytic Procedure Test

• CPK Isoenzymes Chromatographic Separation Test (FDA Code: JHT / 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.

• Creatine Kinase (FDA Code: JLB / 862.1210) A creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle diseases and endocrine disorders including hyperthyroidism.

• Creatine Kinase Myoglobin Kit

• Creatine Phosphate Kinase Reagent Test

• Creatine Phosphokinase Catalytic Method Test

• Creatinine Enzymatic Method Test (FDA Code: JFY / 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.

• Cryostat Microtome (FDA Code: IDP / 864.3010) Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

• Cryostat Microtome Blade Holders

• Cyclic AMP Radioimmunoassay Test (FDA Code: CHO / 862.1230) A cyclic AMP test system is a device intended to measure the level of adenosine 3', 5'-monophosphate (cyclic AMP) in plasma, urine, and other body fluids. Cyclic AMP measurements are used in the diagnosis and treatment of endocrine disorders, including hyperparathyroidism (overactivity of the parathyroid gland). Cyclic AMP measurements may also be used in the diagnosis and treatment of Graves' disease (a disorder of the thyroid) and in the differentiation of causes of hypercalcemia (elevated levels of serum calcium.)

• Cyclic GMP Radioimmunoassay Test (FDA Code: CGT / 862.1230)

• Cyclosporine (FDA Code: MKW / 862.1235) A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for cyclosporine.

• Cyclosporine and Metabolites Serum Assay (FDA Code: MAR / 862.1235)

• Cyclosporine High Performance Liquid Chromatography (FDA Code: MGS / 862.1235)

• Cystatin C Test (FDA Code: NDY / 862.1225)

• Cytocentrifuge (FDA Code: IFB / 864.3300) A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g., cerebrospinal fluid) and to deposit these cells on a glass microscope slide for cytological examination.

• Cytochemical, Acid Phosphatase (FDA Code: JCI / 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.

• Cytological Collection Fluid (FDA Code: LTY)

• Cytomegalovirus Conjugated Fluorescent Antisera Test (FDA Code: LIN / 866.3175) Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.

• Cytomegalovirus Enzyme Linked Immunoabsorbent Assay (FDA Code: LFZ / 866.3175)

• Cytomegalovirus IgM Enzyme Immunoassay

• 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.

• Detection Kits Myoglobin Detection Kit

• Detergent (FDA Code: JCB / 864.4010)

• Determination Of Alkaline Phosphatase

• Diabetes and Obesity Immunoassay Kits

• Diazo AST/SGOT (FDA Code: CIQ / 862.1100) An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

• Differential Blood Cell Counters

• Differential Cell Counter (FDA Code: GKZ / 864.5220) An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

• Differential Rate Kinetic Method, Isoenzymes (FDA Code: JHS / 862.1215)

• Digitoxin (3-H) Radioimmunoassay Test (FDA Code: DOB / 862.3300) A digitoxin test system is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

• Digitoxin Enzyme Immunoassay Test (FDA Code: LFM / 862.3300)

• Digoxin Assay

• Digoxin Enzyme Immunoassay Test (FDA Code: KXT / 862.3320) A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

• Digoxin, Enzyme Immunoassay

• Diluting Pipette (FDA Code: GGY / 864.6160) A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.

• Diphenylhydantoin Enzyme Immunoassay Test (FDA Code: DIP / 862.3350) A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.

• Diphenylhydantoin Fluorescence Polarization Immunoassay (FDA Code: LGR / 862.3350)

• Diphenylhydantoin Fluorescent Immunoassay Test (FDA Code: LES / 862.3350)

• Diphenylhydantoin U.V. Spectrometry (FDA Code: LDC / 862.3350)

• 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.

• Disposable Basic Labware

• DNA Sequencing System

• Drug Mixture Calibrator (FDA Code: DKB / 862.3200) A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also 862.2 in this part.)

• Drug Mixture Control Materials (FDA Code: DIF / 862.3280) A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

• Drug Specific Calibrator (FDA Code: DLJ / 862.3200)