Profile: Roche discovers, develops and provides diagnostic & therapeutic products. Our product area includes pharmaceuticals, solutions for diagnostics and products for researchers. Our pharmaceutical products include actemra, anaprox, avastin, bactrim, bondronat, cellcept, dilatrend, fuzeon, herceptin and lariam. Our actemra is an Interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody developed for the treatment of rheumatoid arthritis. Our cellcept is used in the prevention of organ rejection in patients undergoing kidney, heart or liver transplantation. Our solutions for diagnostics products include accu-chek aviva system, accu-chek combo, accu-chek compact plus system, accu-chek inform II system, Accutrend® plus system, bone markers for Elecsys® analysers and CoaguChek® XS plus system. Our Accutrend® plus system is a hand-held point of care device used for cardiovascular diseases. It detects cholesterol, glucose, triglyceride and blood lactate level from capillary blood.

FDA Registration Number: 9610126
US Agent: Mike Leslie / Roche Diagnostics Operations, Inc.
Phone: +1-(317)-521-4343  Fax: +1-(317)-521-6915  E-Mail:

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• 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.

• Carcinoembryonic Antigen Test System (FDA Code: DHX / 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.

• Cardiac C-Reactive Protein Antiserum Antigen Control (FDA Code: NQD / 866.5270) A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

• Ceruloplasmin Immunochemical (FDA Code: CHN / 866.5210) A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

• 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.

• Cholinesterase Colorimetry Test (FDA Code: DIH / 862.3240) A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

• Clearing Agent (FDA Code: KEM / 864.4010)

• Clinical Colorimeter (FDA Code: JJQ / 862.2300) A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.

• Clinical Refractometer (FDA Code: JRE / 862.2800) A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.

• Cocaine and Cocaine Metabolites Enzyme Immunoassay Test (FDA Code: DIO / 862.3250) A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

• Cocaine Enzyme Immunoassay Test (FDA Code: JXO / 862.3250)

• Colorimetric SGPT Test (FDA Code: CKD / 862.1030) An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

• Colorimetric Uric Acid Test (FDA Code: KNK / 862.1775) A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

• Complement C3 (FDA Code: CZW / 866.5240) A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

• Complement C4 (FDA Code: DBI / 866.5240)

• Control Antiserum Antigen Ferritin IGA (FDA Code: CZM / 866.5510) An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

• 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.

• 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)

• Cystine Nitroprusside Reaction (Qualitative, Urine) (FDA Code: JLC / 862.1240) A cystine test system is a device intended to measure the amino acid cystine in urine. Cystine measurements are used in the diagnosis of cystinuria (occurrence of cystine in urine). Patients with cystinuria frequently develop kidney calculi (stones).

• 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.

• Detergent (FDA Code: JCB / 864.4010)

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

• Digitoxin Enzyme Immunoassay Test (FDA Code: LFM / 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.

• Digoxin (125-I) Radioimmunoassay (FDA Code: LCS / 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 Test (FDA Code: KXT / 862.3320)

• Diphenylhydantoin (Free) Fluorescence Polarization Immunoassay (FDA Code: MOJ / 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 Enzyme Immunoassay Test (FDA Code: DIP / 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.

• 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)

• Drug Specific Control Test (FDA Code: LAS / 862.3280)

• 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.

• Enzyme Controls (FDA Code: JJT / 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.

• Estradiol Radioimmunoassay Test (FDA Code: CHP / 862.1260) An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

• Ferritin (FDA Code: DBF / 866.5340) A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

• Ferritin Radioimmunoassay Test (FDA Code: JMG / 866.5340)

• Ferrozine Iron Binding Capacity Test (FDA Code: JMO / 862.1415) An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

• Fibrin Split Products (FDA Code: GHH / 864.7320) A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).

• Fibrinogen and Fibrin Split Products (FDA Code: DAP / 864.7320)

• Fluorescence Polarization Immunoassay for Cyclosporine (FDA Code: MGU / 862.1235)

• Fluorescent Immunoassay Gentamicin Test (FDA Code: LCQ / 862.3450) A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

• Folic Acid Radioimmunoassay (FDA Code: CGN / 862.1295) A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.

• Follicle Stimulating Hormone Radioimmunoassay (FDA Code: CGJ / 862.1300) A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

• Free Thyroxine Radioimmunoassay (FDA Code: CEC / 862.1695) A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

• Fructose-1, 6-Diphosphate and NADH (FDA Code: CJC / 862.1040) An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase measurements are used in the diagnosis and treatment of the early stages of acute hepatitis and for certain muscle diseases such as progressive Duchenne-type muscular dystrophy.

• Gamma Chain Specific Control (FDA Code: DFZ / 866.5510)