Sentinel Diagnostics CK-MB - HSA Registration DE0012240
Access comprehensive regulatory information for Sentinel Diagnostics CK-MB 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 DE0012240 and owned by Sentinel CH. SpA. The device was registered on January 31, 2013.
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 CK-MB assay is intended for in vitro diagnostic use in the kinetic determination of the CK-MB and CK-BB isoenzymes of creatine kinase in serum or plasma on the ARCHITECT c Systems. Measurement of the CK- MB and CK-BB isoenzymes is used as an aid in the diagnosis and follow-up of patients suspected of having an acute myocardial infarction (AMI). For laboratory professional use only.