Singapore HSA registration DE0509087
Ortho-Clinical VITROS Immunodiagnostic Products IL6 Assay
Singapore·CLASS B IVD·Ortho-Clinical Diagnostics·Registered March 21, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509087
- Registration Date
- March 21, 2024
- Retention Due Date
- March 20, 2026
Product description
VITROS Immunodiagnostic Products IL-6 reagent pack quantitatively measures interleukin-6 in human serum and plasma using the automated VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. Interleukin-6 measurements are useful in the detection and evaluation of inflammatory disease.
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 IL-6 Reagent Pack VITROS Immunodiagnostic Products IL-6 Calibrators VITROS Immunodiagnostic Products IL-6 Controls
- Model Identifier(s)
- 6199971 6199972 6199973
About this record
Access comprehensive regulatory information for Ortho-Clinical VITROS Immunodiagnostic Products IL6 Assay 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 DE0509087 and owned by Ortho-Clinical Diagnostics. The device was registered on March 21, 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 B IVD