Nova Stat pHOX CO-Oximeter - HSA Registration DE0006440
Access comprehensive regulatory information for Nova Stat pHOX CO-Oximeter 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 DE0006440 and owned by Nova Biomedical. The device was registered on March 31, 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 Stat Profile pHOx CO-Oximeter is intended for in vitro diagnostic use by health care professionals in clinical settings for the quantitative determination of oxyhemoglobin, carboxyhemoglobin, methemoglobin, and deoxyhemoglobin in human blood. From the directly measured results, the following parameters are calculated: • Total Hemoglobin (tHb) • Oxygen Saturation (SO2%) • Oxygen Content of Hemoglobin (O2Ct) • Oxygen Capacity of Hemoglobin (O2Cap) When interfaced with the Stat Profile® pHOx® Analyzer, the pHOx Analyzer calculates these parameters. When interfaced with the Stat Profile® Ultra Analyzer, the following parameters are calculated using the results from both analyzers: • Oxygen Content of Blood (O2Ct(B)) • Base Excess of Blood (BE-B, sometimes called in vitro Base Excess) • Standard Bicarbonate Concentration (SBC) • PO2 at 50% SO2 (P50)