Abbott Point of Care I-STAT® Cartridges (Chem8+, 6+, EC4+, E3+, G) - HSA Registration DE0007256
Access comprehensive regulatory information for Abbott Point of Care I-STAT® Cartridges (Chem8+, 6+, EC4+, E3+, G) 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 DE0007256 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.
I-STAT Cartridges Chem8+, 6+, EC4+, E3+, and G are intended to be use with I-Stat® Portable Clinical Analyzer (Model 200) and I-Stat® 1 Analyzer (Model 300) for in vitro quantification of the following analytes in whole blood, respectively: Chem8+: sodium; potassium; chloride; TCO2; anion gap; ionized calcium; glucose; urea nitrogen; creatine; hemtatocrit; hemoglobin; 6+: sodium; potassium; chloride; glucose; urea nitrogen; hemtatocrit; hemoglobin; EC4+: sodium; potassium; chloride; glucose; hemtatocrit; hemoglobin; E3+: sodium; potassium; hemtatocrit; hemoglobin; and G: glucose. All cartridges should be used by healthcare professional trained to use the system.