Ortho-Clinical VITROS Chemistry Products HbA1c Reagent Kit - HSA Registration DE0504647
Access comprehensive regulatory information for Ortho-Clinical VITROS Chemistry Products HbA1c Reagent Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0504647 and owned by Ortho-Clinical Diagnostic Inc. The device was registered on June 30, 2020.
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.
For in vitro diagnostic use only. VITROS Chemistry Products HbA1c reagent is used on the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. The test is to be used as an aid in diagnosis of diabetes, as an aid in identifying patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.