Profile: Roche Diagnostics offers diagnostic tests and systems in the area of integrated healthcare solutions. Our products cover the early detection, targeted screening, evaluation and monitoring of the disease. We are active in the fields of pharmaceuticals and diagnostics. We are associated with diabetes care, blood coagulation monitoring and hospital & laboratory systems. Our diabetes care products include Accu-Chek blood glucose meters, lancet devices, test strips, and diabetes management software.

The company has revenues of USD 100-500 Million, has ~140 employees and is ISO 9000, CE certified.

101 to 132 of 132 Products/Services (Click for related suppliers)  Page: 1 2 [3]

• Plasma Coagulation Control (FDA Code: GGN / 864.5425) A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

• Point-of-Care (POC) Diagnostic Devices

• 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.

• Primary Calibrator (FDA Code: JIS / 862.1150) A 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. (See also 862.2 in this part.)

• Procainamide Enzyme Immunoassay Test (FDA Code: LAR / 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.

• Propoxyphene Enzyme Immunoassay (FDA Code: JXN / 862.3700) A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.

• Prostate Specific Antigen Test (FDA Code: MTG)

• Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer Total (FDA Code: MTF)

• Prostate-Specific Antigen for Management of Prostate Cancers (FDA Code: LTJ / 866.6010) A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

• Prothrombin Time Test (FDA Code: GJS / 864.7750) A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

• Purple Bromcresol Albumin Dye-Binding Test (FDA Code: CJW / 862.1035) An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

• Quinidine Enzyme Immunoassay Test (FDA Code: LBZ / 862.3320)

• RIA Digoxin Control Serum (FDA Code: DMP / 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.

• Rubella Enzyme Linked Immunoabsorbent Assay (FDA Code: LFX / 866.3510) Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).

• Salicylate Colorimetry Test (FDA Code: DKJ / 862.3830) A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

• Secondary Calibrator (FDA Code: JIT / 862.1150)

• 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.

• Testing Strips

• Theophylline Enzyme Immunoassay Test (FDA Code: KLS / 862.3880) A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

• Tobramycin Fluorescence Polarization Immunoassay Test (FDA Code: LFW / 862.3900) A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

• Tobramycin Radioimmunoassay (FDA Code: KLB / 862.3900)

• Total Protein Biuret Method (FDA Code: CEK / 862.1635) A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

• Total Protein Turbidimetric Test (FDA Code: JGQ / 862.1635)

• Total Thyroxine Non-Radiolabeled Enzyme Immunoassay (FDA Code: KLI / 862.1700) A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

• Toxoplasma Gondii Enzyme Linked Immunoabsorbent Assay (FDA Code: LGD / 866.3780)

• Triglycerides Lipase Hydrolysis/Glycerol Kinase Enzyme Test (FDA Code: CDT / 862.1705) A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

• Triiodothyronine Uptake Radioassay (FDA Code: KHQ / 862.1715) A triiodothyronine uptake test system is a device intended to measure the total amount of binding sites available for binding thyroid hormone on the thyroxine-binding proteins, thyroid-binding globulin, thyroxine-binding prealbumin, and albumin of serum and plasma. The device provides an indirect measurement of thyrkoxine levels in serum and plasma. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders.

• Troponin Subunit Enzymatic Method (FDA Code: MMI / 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.

• Urea Nitrogen Urease and Glutamic Dehydrogenase Test (FDA Code: CDQ / 862.1770) A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

• 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.

• 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.