AgaMatrix, Inc.

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Web: http://www.agamatrix.com
E-Mail:
Address: 10 Manor Parkway, Salem, New Hampshire 03079, USA
Phone: +1-(603)-328-6000/866-906-4197 | Fax: +1-(617)-588 0430 | Map/Directions >>

Profile: AgaMatrix, Inc. develops and manufactures a line of diabetes products, which are designed to improve the quality of diabetes care. Our WaveSense technology personalizes each test to provide accuracy. It detects and corrects errors caused by differences in blood samples and environmental conditions. Our product range includes Keynote, Keynote Pro, Presto, Jazz and Zero-Click™. Our Zero-Click™ is a data management software which allows users and healthcare professionals to download blood glucose meter results from WaveSense™. It is installed in four languages such as English, French, Spanish and German. Our Presto does not require code, has backlight and alternate site testing. It has on screen graphing, 6 user settable alarms and hypo/hyperglycemic warning alarms.

FDA Registration Number: 3004637226

5 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 Data Management Systems

• Blood Glucose Monitoring Systems

• 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)