Oem Systems Co. Ltd.

Contact: Patricia Klimley
Address: 84 Mekawa Makishima-Cho, Uji-Shi Kyoto 6110041, Japan
Phone: +81-(510)-7416263 | Map/Directions >>

Profile: Oem Systems Co. Ltd. focuses on abnormal hemoglobin quantitation tests and glycosylated hemoglobin assay tests. Our products include clinical enzyme analyzers and hemoglobin & hematocrit measurement calibrators.

FDA Registration Number: 1000487132
US Agent: Kenneth Block / Ken Block Consulting
Phone: +1-(972)-480-9554 Fax: +1-(972)-767-4325 E-Mail:

5 Products/Services (Click for related suppliers)

• Abnormal Hemoglobin Quantitation Test (FDA Code: GKA / 864.7415)

An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.

• 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 Enzyme Analyzer (FDA Code: JJI / 862.2500)

An enzyme analyzer for clinical use is a device intended to measure enzymes in plasma or serum by nonkinetic or kinetic measurement of enzyme-catalyzed reactions. This device is used in conjunction with certain materials to measure a variety of enzymes as an aid in the diagnosis and treatment of certain enzyme-related disorders.

• 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 and Hematocrit Measurement Calibrator (FDA Code: KRZ / 864.8165)

A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.