Abbott Point of Care i-STAT BNP Cartridge - HSA Registration DE0007258
Access comprehensive regulatory information for Abbott Point of Care i-STAT BNP 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 DE0007258 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 for the quantitative measurement of B-type natriuretic peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure. The cartridge is to be used with the i-STAT 1 Analyzer bearing the symbol, but not with the i-STAT Portable Clinical Analyzer or the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-STAT System, the BNP test is to be used by trained health care professionals in accordance with a facility’s policies and procedures.