Nova StatStrip Glucose and ß-Ketone Hospital Meter System - HSA Registration DE0506901
Access comprehensive regulatory information for Nova StatStrip Glucose and ß-Ketone Hospital Meter 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 DE0506901 and owned by Nova Biomedical. The device was registered on May 31, 2022.
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 Glucose and ß-Ketone Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonate heel stick specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy. It is also intended for the quantitative determination of β-Ketone in capillary finger stick and venous whole blood throughout all hospital and all professional healthcare settings. The system should only be used with single-use, autodisabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia and ketonemia.