Singapore HSA registration DE0504846
Ortho-Clinical VITROS Immunodiagnostic Products NT-proBNP II Assay
Singapore·CLASS C IVD·Ortho-Clinical Diagnostics·Registered August 19, 2020Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0504846
- Registration Date
- August 19, 2020
- Change Notification Approval Date
- December 02, 2020
- Retention Due Date
- August 18, 2025
Product description
For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) to aid in the diagnosis of heart failure and for the risk stratification of acute coronary syndrome and heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with heart failure.
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 NT-proBNP II Reagent Pack VITROS Immunodiagnostic Products NT-proBNP II Calibrators VITROS Immunodiagnostic Products NT-proBNP II Controls
- Model Identifier(s)
- 6844452 6844453 6844507
About this record
Access comprehensive regulatory information for Ortho-Clinical VITROS Immunodiagnostic Products NT-proBNP II 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 DE0504846 and owned by Ortho-Clinical Diagnostics. The device was registered on August 19, 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