Profile: Andon Medical Co., Ltd. deals with blood glucose test systems.
FDA Registration Number: 3008573045
US Agent: Jun Liu / Ihealth Labs, Inc.
Phone: +1-(650)-448-8028 Fax: +1-(650)-292-2222 E-Mail:
4 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. |
• Blood Glucose Test Strips |
• 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. |
• Over-The-Counter Blood Glucose Test System (FDA Code: NBW / 862.1345) |