Abbott Point of Care i-STAT Kaolin Activated Clotting Time Cartridge - HSA Registration DE0007253
Access comprehensive regulatory information for Abbott Point of Care i-STAT Kaolin Activated Clotting Time Cartridge 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 DE0007253 and owned by Abbott Point of Care Inc.. The device was registered on July 11, 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.
It is an in vitro diagnostic test that uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery. The test is to be used with the i-STAT Portable Clinical Analyzer and the i-STAT 1 Analyzer, but not the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM).