Tosoh Corp.

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Contact: Takashi Tsuchiya - Chairman
Web: http://www.tosoh.com
E-Mail:
Address: 3-8-2 Shiba, Minato-Ku, Tokyo, Japan
Phone: +81-(3)-5427-5118 | Fax: +81-(3)-5427-5198 | Map/Directions >>

Profile: Tosoh Corp. is a supplier of chromatographic columns, media and diagnostic systems. Our product list comprises of fully automated random access enzyme immunoassay systems, reagent systems, fully automated glycohemoglobin analyzers, high performance liquid chromatography systems and packing materials for medium pressure liquid chromatography. The AIA®-1800 is our fully-automated random-access enzyme immunoassay system that provides continuous random access, full automation & STAT capability. Our HLC® 8220GPC is a fully automated liquid chromatography system for gel permeation chromatography. It combines a dual solvent delivery system and an optical system, which reduces baseline noise to a very low level.

The company was founded in 1935.

FDA Registration Number: 8031673
US Agent: Milagros Arredondo / Tosoh Bioscience, Inc.
Phone: +1-(650)-636-8148 Fax: +1-(650)-636-8173 E-Mail:

49 Products/Services (Click for related suppliers)

• Alpha-Fetoprotein for Testicular Cancer Test Kit (FDA Code: LOJ / 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.

• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 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.

• Automated Hemoglobin System (FDA Code: GKR / 864.5620)

An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.

• Beta-2-Microglobulin Immunological Test System (FDA Code: JZG / 866.5630)

Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

• C Peptides of Proinsulin Radioimmunoassay Test (FDA Code: JKD / 862.1135)

A C-peptides of proinsulin test system is a device intended to measure C-peptides of proinsulin levels in serum, plasma, and urine. Measurements of C-peptides of proinsulin are used in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus.

• Carbohydrate Antigen (Ca19-9) Test System For Monitoring And Management Of Pancreatic Cancer (FDA Code: NIG / 866.6010)

• Carcinoembryonic Antigen Test System (FDA Code: DHX / 866.6010)

• 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.

• 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.

• 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.

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

• 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.

• 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.

• Fluorometer for Clinical Use (FDA Code: KHO / 862.2560)

A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain materials to measure a variety of analytes.

• Fluorometers (FDA Code: JZT / 866.4520)

Immunofluorometer equipment for clinical use with its electrical power supply is a device used to measure the fluorescence of fluorochrome-labeled antigen-antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light is passed through a solution in which a fluorochrome has been selectively attached to serum protein antibody molecules in suspension. The amount of light emitted by the fluorochrome label is detected by a photodetector, which converts light energy into electrical energy. The amount of electrical energy registers on a readout system such as a digital voltmeter or a recording chart. This electrical readout is called the fluorescence value and is used to measure the concentration of antigen-antibody complexes.

• 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.

• Glycosylated Hemoglobin Assay Test (FDA Code: LCP / 864.7470)

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

• Hemoglobin A2 Quantitation Test (FDA Code: JPD / 864.7400)

A hemoglobin A2assay is a device used to determine the hemoglobin A2content of human blood. The measurement of hemoglobin A2is used in the diagnosis of the thalassemias (hereditary hemolytic anemias characterized by decreased synthesis of one or more types of hemoglobin polypeptide chains).

• Human Chorionic Gonadotropin Agglutination Method (FDA Code: JHJ / 862.1155)

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.

• Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI / 862.1155)

• Human Growth Hormone Radioimmunoassay (FDA Code: CFL / 862.1370)

A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.

• IgE Control (FDA Code: DGC / 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.

• Immunoglobulins D Radioimmunoassay Test (FDA Code: JHR / 866.5510)

• Immunoreactive Insulin Radioimmunoassay Test (FDA Code: CFP / 862.1405)

An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. Immunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia.

• Isoenzymes Fluorometric Method (FDA Code: JHX / 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.

• Luteinizing Hormone Radioimmunoassay (FDA Code: CEP / 862.1485)

A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

• Multi Analyte Control (FDA Code: JJY / 862.1660)

• Myoglobin (FDA Code: DDR / 866.5680)

A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

• Ovarian Tumor-Associated Antigen(Ca 125) Test (FDA Code: LTK / 866.6010)

• Parathyroid Hormone Radioimmunoassay Test (FDA Code: CEW / 862.1545)

A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

• 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.)

• Progesterone Radioimmunoassay Test (FDA Code: JLS / 862.1620)

A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

• Prolactin Radioimmunoassay (FDA Code: CFT / 862.1625)

A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.

• Prostate-Specific Antigen for Management of Prostate Cancers (FDA Code: LTJ / 866.6010)

• Secondary Calibrator (FDA Code: JIT / 862.1150)

• Tartrate Inhibited Acid Phosphatase (FDA Code: JFH / 862.1020)

An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.

• Testosterones and Dihydrotestosterone Radioimmunoassay (FDA Code: CDZ / 862.1680)

A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

• Thyroid Autoantibody Test System (FDA Code: JZO / 866.5870)

A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

• Thyroid Stimulating Hormone Radioimmunoassay (FDA Code: JLW / 862.1690)

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

• Total Lipids Colorimetry Sulfophosphovanillin Test (FDA Code: CFD / 862.1470)

A lipid (total) test system is a device intended to measure total lipids (fats or fat-like substances) in serum and plasma. Lipid (total) measurements are used in the diagnosis and treatment of various diseases involving lipid metabolism and atherosclerosis.

• 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.

• Total Triiodothyronine Radioimmunoassay (FDA Code: CDP / 862.1710)

A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

• 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)

• Tumor Antigen Immunological Test System (FDA Code: MOI / 866.6010)

• 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.