Sekisui Medical Co., Ltd.

Contact: Junichi Inaba
Web: http://www.sekisuimedical.jp
Address: 3-1, Koyodai 3-Chome, Ryugasaki-City, Ibaraki 301-0852, Japan
Phone: +81-(3)-32720674 | Map/Directions >>

Profile: Sekisui Medical Co., Ltd. produces and distribute diagnostic reagents, mainly for testing for infectious and lifestyle-related diseases. We offer test reagents for diseases caused by abnormalities in blood coagulation or fibrinogenolysis and to determine HDL, LDL cholesterol levels. We offer reagents for automated analyzers to measure blood concentrations of drugs. We offer equipment that allows simple, quick and precise testing, such as a compact automated analyzer that can supply test results before your eyes or an easier-to-operate coagulating device. We also offer disposable medical devices for clinical diagnosis, such as plastic vacuum blood collection tubes.

FDA Registration Number: 3003539867
US Agent: Jason Bilobram / Sekisui Diagnostics, Llc
Phone: +1-(781)-652-7848 E-Mail:

7 Products/Services (Click for related suppliers)

• 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.

• HDL Precipitation Method (FDA Code: LBR / 862.1475)

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

• LDL & VLDL Precipitation Method (FDA Code: LBR / 862.1475)

• LDL & VLDL Precipitation, Cholesterol Via Esterase-Oxidase (FDA Code: LBS / 862.1475)

• Lipoprotein Low-Density Test System (FDA Code: MRR / 862.1475)

• 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.)

• Primary Calibrator (FDA Code: JIS / 862.1150)