Infopia Co., Ltd

Contact: Byeong Woo Bae
Address: 889-3, Kwanyang2-Dong, Dongan-Gu, Anyang 431-716, Korea, Republic Of
Phone: +82-(31)-4236170 | Map/Directions >>

Profile: Infopia Co., Ltd deals with blood glucose monitoring systems. Our product line comprises of glucose monitoring system, full automatic bio-chemistry analyzer, mobile healthcare and HbA1C analyzer. The glucose monitoring system is a self-test medical device for an analysis of glucose in whole blood, an elementary diagnosis of diabetes and periodic diabetics controls. Our full automatic bio-chemistry analyzer is a clinical analyzer that measures and analyzes the chemical elements like enzymes, electrolytes, metabolites, cholesterol & proteins in blood serum by photo-chemistry, and examines the validity.

The company is ISO9002 certified.

FDA Registration Number: 3004146366
US Agent: Priscilla Chung / Lk Consulting Group Usa, Inc.
Phone: +1-(714)-202-5789 E-Mail:

9 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.

• 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.

• Enzymatic Esterase-Oxidase, Cholesterol (FDA Code: CHH / 862.1175)

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

• Glucose Oxidase, Glucose (FDA Code: CGA / 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.

• 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.

• 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)

• Over-The-Counter Blood Glucose Test System (FDA Code: NBW / 862.1345)

• Triglycerides Colorimetric Method Test (FDA Code: JGY / 862.1705)

A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.