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:

251 to 256 of 256 Products/Services (Click for related suppliers)  Page: 1 2 3 4 5 [6]

• 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.

• 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.

• 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.

• Whole Blood Oximeter (FDA Code: GLY / 864.7500)