Nitto Boseki Co., Ltd. (Medical Division)

Contact: Colin Getty
Web: http://www.nittobo.co.jp
Address: 4-1-28 Kudan-Kita, Chiyoda-Ku, Tokyo 102-0073, Japan
Phone: +81-(3)-32384540 | Map/Directions >>

Profile: Nitto Boseki Co., Ltd. (medical Division) manufactures chemical and medical products. We produce clinical diagnostic reagents, which are used to diagnose any abnormalities to be detected in the body, by measuring specific elements in urine or blood samples. We supply diagnostic reagents for liver, pancreas and kidney functions, & diagnostic reagents for measuring the blood coagulation factor. Our vitro diagnostic reagents are examined by various types of automated analysis equipment. We provide clinical chemistry reagents for liver disease, cardiac disease, diabetic and renal disease. Our hematological reagents are used to determine intravascular coagulation factor and liver function. We also offer immunological reagents for infectious disease, inflammation, tumor, and osteoporoisis.

FDA Registration Number: 1000403749
US Agent: Colin Getty
Phone: +1-(206)-390-5224 E-Mail:

26 Products/Services (Click for related suppliers)

• Alpha-1-Acid-Glycoprotein Antigen (FDA Code: LKL / 866.5420)

Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

• Alpha-1-Antitrypsin (FDA Code: DEM / 866.5130)

Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.

• Alpha-1-Lipoprotein (FDA Code: DER / 866.5580)

Analpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- 1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement ofalpha- 1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).

• Antistreptolysin-Titer/Streptolysin O Reagent (FDA Code: GTQ / 866.3720)

• Antithrombin III Quantitation Test (FDA Code: JBQ / 864.7060)

An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

• Ast/Sgot Nadh Oxidation/Nad Reduction (FDA Code: CIT / 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.

• Bilirubin Diazo Colorimetry Test (FDA Code: CIG / 862.1110)

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

• C-Reactive Protein (CRP), FITC Conjugate (FDA Code: DCK / 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.

• 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)

• Fibrinogen Test (FDA Code: GIS / 864.7340)

A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

• Glucose Hexokinase Test (FDA Code: CFR / 862.1345)

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

• Haptoglobin (FDA Code: DAD / 866.5460)

A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.

• IgG Control (FDA Code: DEW / 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.

• Immunoelectrophoretic, Immunoglobulins (G, A, M) (FDA Code: CFF / 866.5510)

• Isoenzymes NAD Reduction/NADH Oxidation (FDA Code: CGS / 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.

• Low Density Lipoprotein (FDA Code: DFC / 866.5600)

A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

• Multi Analyte Control (FDA Code: JJY / 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.

• Multi Analyte Mixture - Calibrator (FDA Code: JIX / 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.)

• Plasminogen (FDA Code: DDX / 866.5715)

A plasminogen immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the plasminogen (an inactive substance from which plasmin, a blood-clotting factor, is formed) in serum, other body fluids, and tissues. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders.

• Prealbumin Antiserum (FDA Code: JZJ / 866.5060)

A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.

• Primary Calibrator (FDA Code: JIS / 862.1150)

• Protein /Albumin Turbidimetric Method (FDA Code: JIQ / 862.1645)

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

• Rheumatoid Factor Test System (FDA Code: DHR / 866.5775)

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

• Transferrin Antigen (FDA Code: DDG / 866.5880)

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

• Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR / 862.1645)