Singapore HSA registration DE0509141
Ortho-Clinical VITROS Chemistry Products wrCRP Reagent
Singapore·CLASS C IVD·Ortho-Clinical Diagnostics Inc·Registered April 08, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509141
- Registration Date
- April 08, 2024
- Retention Due Date
- April 07, 2026
Product description
For in vitro diagnostic and laboratory professional use. VITROS Chemistry Products wrCRP Reagent quantitatively measures C-reactive protein (CRP) concentration in serum and plasma (lithium heparin, sodium heparin) using the automated VITROS 4600 Chemistry System and the VITROS 5600/XT 7600 Integrated Systems. Measurements of CRP are used in the evaluation of inflammatory disorders, tissue injury, and infections. CRP measurements with the Ultrasensitive Method aid in identification and stratification of individuals at risk for cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, CRP may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndrome.
Product Owner
- Short Name
- Ortho-Clinical Diagnostics Inc
- Address
- 100 Indigo Creek Drive, Rochester, New York, UNITED STATES
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 Chemistry Products Calibrator Kit 34 VITROS Chemistry Products wrCRP Reagent
- Model Identifier(s)
- 6907789 6922333
About this record
Access comprehensive regulatory information for Ortho-Clinical VITROS Chemistry Products wrCRP Reagent 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 DE0509141 and owned by Ortho-Clinical Diagnostics Inc. The device was registered on April 08, 2024.
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