Nova StatStrip Glucose Monitoring System - HSA Registration DE0008107
Access comprehensive regulatory information for Nova StatStrip Glucose Monitoring System in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0008107 and owned by Nova Biomedical. The device was registered on December 02, 2011.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Nova StatStrip Xpress Glucose Hospital Meter System is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of Glucose (Glu) in capillary, venous, arterial, and neonatal whole blood. The Nova StatStrip Glucose Test Strips are intended for use only with StatStrip Glucose Meter for quantitative tests. The Glucose Meter is intended to quantitatively measure glucose (sugar) in whole blood. The Glucose Meter is plasma calibrated to allow easy comparison of results with laboratory methods. Nova StatStrip Glucose Test Strips are for testing outside the body (in vitro diagnostic use). Nove StatStrip Glucose Control Solution Used as a quality control check to ensure that the StatStrip Glucose Meter and the Glucose Meter Test Strips are working properly as a system. Nova StatStrip Glucose Linearity Kit The Linearity solutions are used to check the linearity of the StatStrip Glucose Meter System.