Singapore HSA registration DE0504438
Ortho-Clinical VITROS Immunodiagnostic Products hs Troponin I Assay
Singapore·CLASS C IVD·Ortho-Clinical Diagnostics·Registered May 05, 2020Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0504438
- Registration Date
- May 05, 2020
- Change Notification Approval Date
- October 19, 2020
- Retention Due Date
- May 04, 2026
Product description
For in vitro diagnostic use only. For the quantitative measurement of cardiac troponin I (cTnI) in human serum and plasma (heparin) using the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. Cardiac troponin I elevations are associated with myocardial damage, and in patients with acute coronary syndrome (ACS), troponin values are used to aid in the diagnosis of myocardial infarction (MI). The test is further indicated for risk stratification of mortality, myocardial infarction or coronary revascularization in patients with acute coronary syndrome.
Product Owner
- Short Name
- Ortho-Clinical Diagnostics
- Address
- Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, UNITED KINGDOM
Registrant
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
- Model Name(s)
- VITROS Immunodiagnostic Products hs Troponin I Reagent Pack VITROS Immunodiagnostic Products hs Troponin I Calibrators VITROS Immunodiagnostic Products hs Troponin I Low Control
- Model Identifier(s)
- 6844436 6844437 6900040
About this record
Access comprehensive regulatory information for Ortho-Clinical VITROS Immunodiagnostic Products hs Troponin I Assay 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 DE0504438 and owned by Ortho-Clinical Diagnostics. The device was registered on May 05, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD