Roche Diagnostics cobas® Tina-quant Cardiac high sensitivity CRP III - HSA Registration DE0510574
Access comprehensive regulatory information for Roche Diagnostics cobas® Tina-quant Cardiac high sensitivity CRP III 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 DE0510574 and owned by Roche Diagnostics GmbH. The device was registered on April 10, 2025.
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.
In vitro test for the quantitative determination of C‑reactive protein (CRP) in human serum and plasma on cobas c systems. CRP measurements, performed with this assay, in human serum or plasma, are used as aid in diagnosis, monitoring, prognosis, and management of suspected inflammatory disorders and associated diseases, acute infections and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome.